Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT00985361
Status:
COMPLETED
Last Update Posted:
2010-05-06
First Post:
2009-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-05', 'studyFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2009-09-25', 'lastUpdatePostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22018074', 'type': 'DERIVED', 'citation': 'Soric MM, Renner ET, Smith SR. Effect of daily vitamin D supplementation on HbA1c in patients with uncontrolled type 2 diabetes mellitus: a pilot study. J Diabetes. 2012 Mar;4(1):104-5. doi: 10.1111/j.1753-0407.2011.00164.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.', 'detailedDescription': 'Vitamin D is typically understood to support musculoskeletal health when administered concomitantly with calcium. A number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and debilitating complications of this chronic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Hemoglobin A1c \\>7% measured in the 3 months prior to randomization\n* Age 21 to 75 years\n\nExclusion Criteria:\n\n* Renal insufficiency (defined as CrCl \\<30mL/min)\n* Gestational diabetes\n* Malabsorption syndrome\n* Patients taking vitamin D supplements at doses \\>400 international units daily'}, 'identificationModule': {'nctId': 'NCT00985361', 'briefTitle': 'Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'ProMedica Health System'}, 'officialTitle': 'Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '09-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D 2000 international units daily', 'interventionNames': ['Dietary Supplement: Vitamin D3 2000 international units daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin C 500mg daily', 'interventionNames': ['Dietary Supplement: Vitamin C 500mg daily']}], 'interventions': [{'name': 'Vitamin D3 2000 international units daily', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D3 2000 international unit tablets once daily for 3 months', 'armGroupLabels': ['Vitamin D 2000 international units daily']}, {'name': 'Vitamin C 500mg daily', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin C 500mg tablets once daily for 3 months', 'armGroupLabels': ['Vitamin C 500mg daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43560', 'city': 'Sylvania', 'state': 'Ohio', 'country': 'United States', 'facility': 'Flower Hospital Family Medicine Residency', 'geoPoint': {'lat': 41.71894, 'lon': -83.71299}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Center for Health Services', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Hospital Family Medicine Residency', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Mate M Soric, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ProMedica Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProMedica Health System', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mate Soric', 'oldOrganization': 'ProMedica'}}}}