Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT01797302
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2013-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vitamin D and Vascular Health in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kumaravel.rajakumar@chp.edu', 'phone': '412-692-5822', 'title': 'Kumaravel Rajakumar', 'organization': 'University of Pittsburgh School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our findings of reductions in central-systolic BP and fasting glucose concentrations and improvement in insulin sensitivity lack adjustment for multiplicity and therefore should be considered as hypothesis-generating and interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 24, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 20, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 26, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Injury, poisoning, and proc complications other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Irregular menstruation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rhinitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin and subcutaneous disorders other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Surgical and medical procedures other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flow-mediated Dilation (FMD) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '7.61', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '8.27', 'spread': '5.92', 'groupId': 'OG001'}, {'value': '7.31', 'spread': '5.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term from model group\\*time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.', 'unitOfMeasure': 'percentage of baseline dilation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat with all available data'}, {'type': 'SECONDARY', 'title': 'Pulse-wave Velocity (PWV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '4.85', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '4.85', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '4.88', 'spread': '0.75', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term for group\\*time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to tread with all available data'}, {'type': 'SECONDARY', 'title': 'Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '2.22', 'spread': '10.97', 'groupId': 'OG001'}, {'value': '1.74', 'spread': '10.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'AIx-75 is a measure of arterial stiffness. AIx was measured through radial arterial tonometry using SphygmoCor.\n\nRadial pulse waveform are analyzed through an automatic software function to determine aortic pulse waveform and aortic or central systolic (cSBP) and diastolic blood pressure (cDBP), and these measurements are further analyzed automatically to calculate AIx.\n\nAIx is a composite measure of the magnitude of wave reflection and arterial stiffness in all conduit arteries which affect the timing of the wave reflection. AIx = P2-P1/cSBP-cDBP, where P1 is the height of the incident pressure wave form during systole, P2 is the height of the reflected wave added to the incident wave, cSBP is the aortic systolic BP, and cDBP is the aortic diastolic BP. AIx adjusted to heart rate of 75 beats/min (AIx-75) is a validated index of arterial stiffness, with higher values indicating higher degree of arterial stiffness.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}, {'type': 'SECONDARY', 'title': 'Central Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '98.45', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '96.05', 'spread': '8.19', 'groupId': 'OG001'}, {'value': '98.50', 'spread': '7.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}, {'type': 'SECONDARY', 'title': 'Central Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '68.69', 'spread': '5.87', 'groupId': 'OG000'}, {'value': '65.33', 'spread': '8.27', 'groupId': 'OG001'}, {'value': '68.57', 'spread': '6.58', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0117', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}, {'type': 'SECONDARY', 'title': 'Systemic Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '114.71', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '114.88', 'spread': '11.76', 'groupId': 'OG001'}, {'value': '115.70', 'spread': '9.55', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}, {'type': 'SECONDARY', 'title': 'Systemic Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '67.57', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '64.73', 'spread': '8.44', 'groupId': 'OG001'}, {'value': '67.30', 'spread': '6.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0256', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '88.41', 'spread': '6.33', 'groupId': 'OG000'}, {'value': '88.48', 'spread': '7.05', 'groupId': 'OG001'}, {'value': '90.44', 'spread': '6.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0945', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}, {'type': 'SECONDARY', 'title': '1/Fasting Insulin Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': '1/fasting insulin ratio is a measure of insulin sensitivity. Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'OG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'classes': [{'categories': [{'measurements': [{'value': '30.82', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '30.99', 'spread': '6.41', 'groupId': 'OG001'}, {'value': '30.62', 'spread': '6.78', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0094', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'interaction term group\\*time from linear mixed model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'a surrogate measure of adiposity', 'unitOfMeasure': '"kg/m^2"', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat with all available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'FG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'FG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': '3 Month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'BG001', 'title': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'BG002', 'title': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months\n\nVitamin D3: Tablet form'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '13.5', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '13.5', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '13.6', 'spread': '2.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '215', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'American Indian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Hawaiian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '30.3', 'spread': '6.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '"kg/m^2"', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Obese (BMI > or = 95th percentile)', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Serum 25-hydroxyvitamin D (25[OH]D)', 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '14.4', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '4.3', 'groupId': 'BG002'}, {'value': '14.3', 'spread': '3.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum parathyroid hormone (PTH)', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '19.9', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '18.0', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '20.6', 'groupId': 'BG002'}, {'value': '49.8', 'spread': '19.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-02', 'size': 545579, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-03T13:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2013-02-20', 'resultsFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2013-02-20', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-10', 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '6 months', 'description': 'a surrogate measure of adiposity'}], 'primaryOutcomes': [{'measure': 'Flow-mediated Dilation (FMD) Percentage', 'timeFrame': '6 months', 'description': 'Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.'}], 'secondaryOutcomes': [{'measure': 'Pulse-wave Velocity (PWV)', 'timeFrame': '6 months', 'description': 'PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness.'}, {'measure': 'Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)', 'timeFrame': '6 months', 'description': 'AIx-75 is a measure of arterial stiffness. AIx was measured through radial arterial tonometry using SphygmoCor.\n\nRadial pulse waveform are analyzed through an automatic software function to determine aortic pulse waveform and aortic or central systolic (cSBP) and diastolic blood pressure (cDBP), and these measurements are further analyzed automatically to calculate AIx.\n\nAIx is a composite measure of the magnitude of wave reflection and arterial stiffness in all conduit arteries which affect the timing of the wave reflection. AIx = P2-P1/cSBP-cDBP, where P1 is the height of the incident pressure wave form during systole, P2 is the height of the reflected wave added to the incident wave, cSBP is the aortic systolic BP, and cDBP is the aortic diastolic BP. AIx adjusted to heart rate of 75 beats/min (AIx-75) is a validated index of arterial stiffness, with higher values indicating higher degree of arterial stiffness.'}, {'measure': 'Central Systolic Blood Pressure', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health'}, {'measure': 'Central Diastolic Blood Pressure', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health'}, {'measure': 'Systemic Systolic Blood Pressure', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health'}, {'measure': 'Systemic Diastolic Blood Pressure', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health'}, {'measure': 'Fasting Blood Glucose', 'timeFrame': '6 months', 'description': 'a measure of cardiometabolic health'}, {'measure': '1/Fasting Insulin Ratio', 'timeFrame': '6 months', 'description': '1/fasting insulin ratio is a measure of insulin sensitivity. Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Vitamin D Deficiency', 'Vascular Function', 'Insulin resistance', 'metabolic syndrome'], 'conditions': ['Obesity', 'Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '31950134', 'type': 'RESULT', 'citation': 'Rajakumar K, Moore CG, Khalid AT, Vallejo AN, Virji MA, Holick MF, Greenspan SL, Arslanian S, Reis SE. Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial. Am J Clin Nutr. 2020 Apr 1;111(4):757-768. doi: 10.1093/ajcn/nqz340.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we will test the central hypothesis that enhancement of vitamin D status in obese and overweight children will improve their vascular health and their cardiovascular disease (CVD) and metabolic syndrome risk profile.', 'detailedDescription': 'Our primary objective is to determine, in obese and overweight children aged 10 to 18 years with vitamin D deficiency (defined as serum 25-hydroxyvitamin D \\<20 ng/mL), the efficacy of enhanced vitamin D3 supplementation in improving vascular endothelial function, arterial stiffness, insulin sensitivity, and metabolic syndrome risk status; and to assess whether these effects are dose-dependent. As a secondary objective, we will examine the vitamin D supplementation-induced effect on adipokines and inflammatory markers relevant to CVD risk. In a double-masked, controlled trial, we will randomize 252 eligible children to receive either 600 IU (conventional supplementation), or 1000 IU or 2000 IU (enhanced supplementation) of vitamin D3 daily for 6 months.\n\nIn terms of reporting of results, the following pre-specified outcomes are included in the primary manuscript (PubMed PMID:31950134 -- see Reference section for citation details)\n\n1. Waist Circumference\n2. Serum High Density Lipoprotein (HDL) Cholesterol\n3. Serum Triglycerides\n4. Inflammatory markers (Plasma TNF-alpha, high-sensitivity C-reactive protein, and IL-6)\n5. Adiopkines (Plasma Leptin and Adiponectin)\n\nPlasma nitric oxide metabolites were not measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects will be 10 to 18 years of age;\n* obese or overweight (BMI ≥85th %tile);\n* otherwise healthy, and\n* have a serum 25(OH)D concentration \\<20 ng/mL\n\nChildren taking multivitamins should be able to hold off their multivitamins during the course of the study.\n\nExclusion Criteria:\n\nChildren will be excluded if they\n\n* (a) have hepatic or renal disease, metabolic rickets, malabsorptive disorders, primary hyperparathyroidism, hyperthyroidism, or other chronic disorders that could affect vitamin D metabolism;\n* (b) are receiving treatment with anticonvulsants, systemic glucocorticoids, pharmacologic doses of vitamin D (≥1000 IU of vitamin D2 or D3 daily), antihypertensives, vasoactive drugs, antilipidemics, metformin, antipsychotics, or other oral insulin regulators;\n* (c) have cholelithiasis or urolithiasis;\n* (d) have type 1 or type 2 diabetes; or\n* (e) have a condition or underlying abnormality that could compromise the safety of the subject.\n\nPost-menarchial girls with a positive pregnancy test at randomization, or subjects found during the screening phase to have hypercalcemia (serum calcium \\>10.8 mg/dL) or significant fasting hyperglycemia (fasting blood glucose ≥ 125 mg/dL) will also be excluded.'}, 'identificationModule': {'nctId': 'NCT01797302', 'briefTitle': 'Vitamin D and Vascular Health in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Vitamin D and Vascular Function in Obese Children', 'orgStudyIdInfo': {'id': 'PRO12100034'}, 'secondaryIdInfos': [{'id': 'R01HL112985', 'link': 'https://reporter.nih.gov/quickSearch/R01HL112985', 'type': 'NIH'}, {'id': '5R01HL112985-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL112985-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D3 2000 IU', 'description': 'Vitamin D3 2000 IU tablet once daily by mouth for 6 months', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D3 1000 IU', 'description': 'Vitamin D3 1000 IU tablet by mouth once daily for 6 months', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vitamin D3 600 IU', 'description': 'Vitamin D3 600 IU tablet by mouth once daily for 6 months', 'interventionNames': ['Dietary Supplement: Vitamin D3']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cholecalciferol'], 'description': 'Tablet form', 'armGroupLabels': ['Vitamin D3 1000 IU', 'Vitamin D3 2000 IU', 'Vitamin D3 600 IU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Primary Care Center, Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Kumaravel Rajakumar, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Office of Dietary Supplements (ODS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Kumaravel Rajakumar', 'investigatorAffiliation': 'University of Pittsburgh'}}}}