Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT00621257
Status:
TERMINATED
Last Update Posted:
2017-03-22
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D Levels in Children With IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}, {'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': 'helen.pappa@childrens.harvard.edu', 'phone': '617-355-6058', 'title': 'Helen Pappa, MD, MPH, Principal Investigator', 'organization': "children's Hospital Boston"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks while participant was on study medication for treatment trial', 'description': 'For 1 year, while participant was on study medication for the maintenance trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A', 'description': '2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)\n\nergocalciferol: 8000 units/ml', 'otherNumAtRisk': 24, 'otherNumAffected': 5, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B', 'description': '2,000 IU/day of vitamin D3 orally for 6 weeks\n\nCholecalciferol: 400 units per drop', 'otherNumAtRisk': 24, 'otherNumAffected': 8, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C', 'description': '50,000 IU of vitamin D2 once a week orally for 6 weeks\n\nergocalciferol: 8000 units/ml', 'otherNumAtRisk': 23, 'otherNumAffected': 4, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Maintenance A', 'description': '400 IU per day of oral vitamin D2\n\nergocalciferol 8000 IU/ml', 'otherNumAtRisk': 32, 'otherNumAffected': 19, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Maintenance B', 'description': '1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April\n\nergocalciferol 8000 IU/ml', 'otherNumAtRisk': 31, 'otherNumAffected': 15, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'itching skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'irregular heart beat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sensitive eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash on face and body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unusual tiredness, or weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metallic taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Calcium deposit in tissues outside of bones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': '2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)\n\nergocalciferol: 8000 units/ml'}, {'id': 'OG001', 'title': 'Treatment B', 'description': '2,000 IU/day of vitamin D3 orally for 6 weeks\n\nCholecalciferol: 400 units per drop'}, {'id': 'OG002', 'title': 'Treatment C', 'description': '50,000 IU of vitamin D2 once a week orally for 6 weeks\n\nergocalciferol: 8000 units/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '25.4', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease.\n\n25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance A', 'description': '400 IU/day of vitamin D2 orally over 2 years (control arm)\n\nergocalciferol: 8000 units/ml'}, {'id': 'OG001', 'title': 'Maintenance B', 'description': '2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years\n\nergocalciferol: 8000 units/ml'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment A', 'description': '2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)\n\nergocalciferol: 8000 units/ml'}, {'id': 'FG001', 'title': 'Treatment B', 'description': '2,000 IU/day of vitamin D3 orally for 6 weeks\n\nCholecalciferol: 400 units per drop'}, {'id': 'FG002', 'title': 'Treatment C', 'description': '50,000 IU of vitamin D2 once a week orally for 6 weeks\n\nergocalciferol: 8000 units/ml'}, {'id': 'FG003', 'title': 'Maintenance A', 'description': '400 IU/day of vitamin D2 orally over 2 years (control arm)\n\nergocalciferol: 8000 units/ml'}, {'id': 'FG004', 'title': 'Maintenance B', 'description': '2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years\n\nergocalciferol: 8000 units/ml'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '134', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment A', 'description': '2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)\n\nergocalciferol: 8000 units/ml'}, {'id': 'BG001', 'title': 'Treatment B', 'description': '2,000 IU/day of vitamin D3 orally for 6 weeks\n\nCholecalciferol: 400 units per drop'}, {'id': 'BG002', 'title': 'Treatment C', 'description': '50,000 IU of vitamin D2 once a week orally for 6 weeks\n\nergocalciferol: 8000 units/ml'}, {'id': 'BG003', 'title': 'Maintenance A', 'description': '400 IU/day of vitamin D2 orally over 2 years (control arm)\n\nergocalciferol: 8000 units/ml'}, {'id': 'BG004', 'title': 'Maintenance B', 'description': '2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years\n\nergocalciferol: 8000 units/ml'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '3', 'groupId': 'BG000'}, {'value': '14.7', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '16.3', 'spread': '3.2', 'groupId': 'BG002'}, {'value': '15.1', 'spread': '3.1', 'groupId': 'BG003'}, {'value': '14.5', 'spread': '3.1', 'groupId': 'BG004'}, {'value': '15.2', 'spread': '3.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'whyStopped': 'Maintenance phase outcome unattenable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-18', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-27', 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease', 'timeFrame': '6 weeks', 'description': 'Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease.\n\n25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores.'}], 'secondaryOutcomes': [{'measure': 'Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease', 'timeFrame': '12 months', 'description': 'Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IBD', 'Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis', 'Vitamin D'], 'conditions': ['Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '24926949', 'type': 'DERIVED', 'citation': 'Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Bronzwaer ME, Koenen M, Gordon CM. Maintenance of optimal vitamin D status in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing two regimens. J Clin Endocrinol Metab. 2014 Sep;99(9):3408-17. doi: 10.1210/jc.2013-4218. Epub 2014 Jun 13.'}, {'pmid': '22456619', 'type': 'DERIVED', 'citation': 'Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Varvaris M, Van Straaten S, Gordon CM. Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens. J Clin Endocrinol Metab. 2012 Jun;97(6):2134-42. doi: 10.1210/jc.2011-3182. Epub 2012 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'Research has shown that children with Inflammatory Bowel Disease may have lower levels of vitamin D than healthy children, especially in the winter. Vitamin D is important for growing and maintaining healthy bones throughout life, and this is particularly important, since children with IBD frequently have low bone density. It may also be helpful in the treatment of IBD itself, because it helps reduce inflammation. Vitamin D levels are measured by the amount of 25 OHD in the blood; however, measuring this level on a regular basis is not yet the standard for children with IBD. The purpose of this study is to find the best way to treat low vitamin D levels, and to maintain good vitamin D levels throughout the year. It will also test whether having higher vitamin D levels will improve the bone health of children with IBD, and whether it will help them have milder disease.', 'detailedDescription': 'Vitamin D is essential for bone mineralization. The prevalence of vitamin D insufficiency \\[serum 25-hydroxy-vitamin D concentration (25OHD) ≤ 20 ng/mL\\] is high among adults with inflammatory bowel disease (IBD), and even higher in pediatric patients with IBD. Protein-losing enteropathy could represent both an etiologic factor for hypovitaminosis D, and an obstacle in treating it in IBD patients. There are currently no guidelines for the treatment of hypovitaminosis D in adults or children with IBD. Moreover we have obtained evidence that optimal vitamin D stores (25OHD ≥32 ng/mL) may not be maintained throughout the year in patients with IBD following current RDA recommendations. On the other hand, the prevalence of low bone mineral density is high among young patients with IBD, during a period in their lives when they should experience the most rapid acquisition of bone mass. Optimization of vitamin D status and its impact on the bone health of children with IBD has not been studied. In addition, vitamin D may play an important role in the regulation of the immune system as supported by animal models of colitis and in vitro human studies.\n\nProspective studies of the effect of vitamin D supplementation on disease outcomes have not been undertaken in children with IBD to date. We aim to perform a) a randomized controlled trial to compare the efficacy of 3 regimens in treating vitamin D insufficiency in pediatric patients with IBD over a period of 6 weeks. We will also evaluate the effects of each regimen on markers of bone resorption, bone formation and parathyroid hormone levels, and the relationship between the magnitude of gastrointestinal protein loss, as reflected by clearance of fecal alpha -1-antitrypsin, and the efficacy of the treatment. b) We also aim to perform a randomized controlled trial to compare the efficacy of 2 regimens of different doses of oral vitamin D2 in maintaining optimal vitamin D stores in pediatric patients with IBD over a period of 2 years. We intend to study the effect of each regimen on a) bone mass acquisition (measured via DXA and pQCT) and bone strength (measured via pQCT), b) bone formation and resorption markers and parathyroid hormone, and c) disease outcomes and disease severity over the same period of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of inflammatory bowel disease\n* serum 25OHD level ≤ 20 ng/mL (Treatment Trial)\n* serum 25OHD level \\> 20 ng/mL (Maintenance Trial)\n\nExclusion Criteria:\n\n* Patients unable to take medications by mouth, pregnant, with liver/kidney failure, receiving anticonvulsant medications (specifically, phenobarbital, carbamazepine and phenytoin, since they lead to increased vitamin D metabolism through hepatic induction of the cytochrome P450 (CYP450) hydroxylase enzymes), regularly attending a tanning salon (once weekly or more), currently being treated for hypovitaminosis D with therapeutic doses of vitamin D (\\> 800 IU per day) and unwilling to discontinue this regimen.\n* patients on growth hormone, anabolic steroid hormones, calcitonin, bisphosphonates (Maintenance Trial only)'}, 'identificationModule': {'nctId': 'NCT00621257', 'briefTitle': 'Vitamin D Levels in Children With IBD', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD.', 'orgStudyIdInfo': {'id': '1K23DK076979-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK076979-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1K23DK076979-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK076979-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A', 'description': '2,000 IU/day of ergocalciferol orally for 6 weeks (control arm)', 'interventionNames': ['Dietary Supplement: ergocalciferol']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': '2,000 IU/day of cholecalciferol orally for 6 weeks', 'interventionNames': ['Dietary Supplement: Cholecalciferol']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': '50,000 IU of ergocalciferol once a week orally for 6 weeks', 'interventionNames': ['Dietary Supplement: ergocalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maintenance A', 'description': '400 IU/day of ergocalciferol orally over 2 years (control arm)', 'interventionNames': ['Dietary Supplement: ergocalciferol']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance B', 'description': '2,000 IU/day of ergocalciferol orally from November 1 to April 30, and 1,000 IU/day of ergocalciferol orally for the remainder of the year over 2 years', 'interventionNames': ['Dietary Supplement: ergocalciferol']}], 'interventions': [{'name': 'ergocalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin D2'], 'description': '8000 units/ml', 'armGroupLabels': ['Maintenance A', 'Maintenance B', 'Treatment A', 'Treatment C']}, {'name': 'Cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin D3'], 'description': '400 units per drop', 'armGroupLabels': ['Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital, Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Helen Pappa, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': "Crohn's and Colitis Foundation", 'class': 'OTHER'}, {'name': 'NASPGHAN Foundation', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Helen Pappa', 'investigatorAffiliation': "Boston Children's Hospital"}}}}