Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:57 PM
Study NCT ID:
NCT01697228
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2012-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '6 months', 'description': 'The primary endpoint in this study will be the difference in change in Hemoglobin A1c between the treatment and non-treatment periods (6 months)'}], 'secondaryOutcomes': [{'measure': 'Pro-inflammatory markers', 'timeFrame': '6 months', 'description': 'Change in pro-inflammatory markers (CRP, IL-6, TNF-α) between treatment and non-treatment periods'}, {'measure': 'Vitamin D level and proinflammatory markers', 'timeFrame': '6 months', 'description': 'Correlation between change in vitamin D levels and circulating pro-inflammatory markers, including CRP, IL-6, and TNF-α'}, {'measure': 'Vitamin D levels on insulin requirements', 'timeFrame': '6 months', 'description': 'Correlation between the change of vitamin D levels on insulin requirements'}, {'measure': 'Vitamin D level and HbA1c', 'timeFrame': '6 months', 'description': 'Correlation between the change in vitamin D level in the blood and change in HbA1c'}, {'measure': 'Baseline differences between vitamin D deficient & sufficient subjects', 'timeFrame': 'Baseline', 'description': 'Comparison of baseline differences between vitamin D deficient/insufficient subjects and vitamin D sufficient subjects (including pro-inflammatory markers, HbA1c and total daily insulin requirements'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Vitamin D', 'Proinflammatory markers'], 'conditions': ['Type 1 Diabetes', 'Vitamin D Deficiency/Insufficiency']}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a prospective cross-over study to evaluate the effects of vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to see a significant improvement in glycemic control and a reduction of serum pro-inflammatory markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who are treated with vitamin D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between 13 to 21 years of age, with at least Tanner stage 4 sexual maturity for males or post-menarchal females, and T1DM for at least 1 year. To ensure that inclusion criteria for sexual maturity are met, a physical exam for research purposes will be performed.\n2. HbA1c between 7 to 9%\n3. Adequate renal function (serum creatinine \\< 1.5 mg/dL in males and \\< 1.2 mg/dL in females) and adequate liver function (AST and ALT \\< 2.5 times the upper limit of normal)\n4. Vitamin D insufficiency or deficiency (25-OH vit D level \\< 30ng/mL) which will be determined on initial screening labs after consenting subjects.\n\nExclusion Criteria:\n\n1. Less than 13 or greater than 21 years of age\n2. Less than Tanner stage 4 sexual maturity for males or pre-menarche\n3. HbA1c less than 7% or greater than 9%\n4. T1DM for less than 1 year\n5. Vitamin D sufficient (25-OH vit D level \\> 30 ng/mL)\n6. Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs\n7. Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids\n8. Inadequate renal function (serum creatinine \\> 1.5mg/dL in males and \\> 1.2mg/dL in females) or inadequate liver function (AST and ALT \\> 2.5 times the upper limit of normal)\n9. Evidence of malabsorption or short gut.'}, 'identificationModule': {'nctId': 'NCT01697228', 'briefTitle': 'The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'The Effects of Vitamin D Supplementation on Glycemic Control and Proinflammatory Markers Involved in Microvascular Complications in Adolescents With Type 1 Diabetes.', 'orgStudyIdInfo': {'id': '11-00352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Immediate treatment group', 'description': 'This group will receive vitamin D supplementation for the first 6 months, then will be monitored off vitamin D for the next 6 months.', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'OTHER', 'label': 'Delayed treatment group', 'description': 'This group will be monitored for the first 6 months, and then will be given vitamin D for the next 6 months.', 'interventionNames': ['Dietary Supplement: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Delayed treatment group', 'Immediate treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Roshanak Monzavi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Center for Endocrinology, Diabetes, and Metabolism', 'investigatorFullName': 'Roshanak Monzavi MD', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}