Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-30 @ 4:10 AM
Study NCT ID:
NCT01141192
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2010-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-09', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D status', '25-OH D', 'ionized calcium', 'fasting glucose', 'hemoglobin A1c', 'fasting insulin', 'glucose metabolism', 'HOMA index', 'blood lipids', 'type 2 diabetes', 'PTH', 'adiposity', 'body fat percentage', 'dual energy x-ray absorptiometry', 'pulse wave velocity', 'arterial stiffness', 'flow-mediated dilation', 'African American', 'inflammatory markers'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19106328', 'type': 'BACKGROUND', 'citation': 'Liu E, Meigs JB, Pittas AG, McKeown NM, Economos CD, Booth SL, Jacques PF. Plasma 25-hydroxyvitamin d is associated with markers of the insulin resistant phenotype in nondiabetic adults. J Nutr. 2009 Feb;139(2):329-34. doi: 10.3945/jn.108.093831. Epub 2008 Dec 23.'}, {'pmid': '20304061', 'type': 'BACKGROUND', 'citation': 'Pittas AG, Dawson-Hughes B. Vitamin D and diabetes. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):425-9. doi: 10.1016/j.jsbmb.2010.03.042. Epub 2010 Mar 18.'}, {'pmid': '18846051', 'type': 'BACKGROUND', 'citation': 'Voidonikola PT, Stamatelopoulos KS, Alevizaki M, Kollias GE, Zakopoulos NA, Lekakis JP, Anastasiou E, Theodorakis MJ, Pittas AG, Papamichael CM. The association between glycemia and endothelial function in nondiabetic individuals: the importance of body weight. Obesity (Silver Spring). 2008 Dec;16(12):2658-62. doi: 10.1038/oby.2008.431. Epub 2008 Oct 9.'}, {'pmid': '20392893', 'type': 'BACKGROUND', 'citation': 'Liu E, Meigs JB, Pittas AG, Economos CD, McKeown NM, Booth SL, Jacques PF. Predicted 25-hydroxyvitamin D score and incident type 2 diabetes in the Framingham Offspring Study. Am J Clin Nutr. 2010 Jun;91(6):1627-33. doi: 10.3945/ajcn.2009.28441. Epub 2010 Apr 14.'}, {'pmid': '21986705', 'type': 'DERIVED', 'citation': 'Zhu H, Guo D, Li K, Pedersen-White J, Stallmann-Jorgensen IS, Huang Y, Parikh S, Liu K, Dong Y. Increased telomerase activity and vitamin D supplementation in overweight African Americans. Int J Obes (Lond). 2012 Jun;36(6):805-9. doi: 10.1038/ijo.2011.197. Epub 2011 Oct 11.'}]}, 'descriptionModule': {'briefSummary': "Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Researchers have found that the less vitamin D Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for African Americans. The investigators want to better understand how vitamin D status and diabetes risk are linked in African Americans. Also, the investigators want to see if supplementation with vitamin D will improve your blood pressure, blood sugar, \\& insulin. All of these are in some way related to diabetes. The investigators want to measure changes in blood sugar \\& blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes.\n\nThe investigators hypothesize that vitamin D status is related to diabetes risk measured by hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic African American adults and that body weight status may affect vitamin D status in response to vitamin D supplements compared to placebo.", 'detailedDescription': 'Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement every four weeks or an inactive placebo. All investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American by self-report\n* In good health\n\nExclusion Criteria:\n\n* Diagnosis of diabetes\n* Health problems/medication affecting calcium and/or vitamin D metabolism\n* Current use of vitamin/mineral/herbal/nutritional supplements\n* Inability to swallow pills\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01141192', 'acronym': 'AVIS', 'briefTitle': 'The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults', 'orgStudyIdInfo': {'id': '0910091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D3 supplement', 'description': '60,000 IU vitamin D3 oral supplement provided every four weeks at weeks 0, 4, 8, and 12 in the form of one 50,000 and two 5,000 IU vitamin D3 supplements in gelcap form.', 'interventionNames': ['Dietary Supplement: vitamin D3, cholecalciferol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'Inactive placebo tablets identical in appearance to the active comparator provided every four weeks at weeks 0,4,8,and 12.', 'interventionNames': ['Dietary Supplement: Inactive comparator']}], 'interventions': [{'name': 'vitamin D3, cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 gelcap of 50,000 IU vitamin D3 plus 2 gelcaps of 5,000 IU vitamin D3 each; a total of 60,000 IU vitamin D3 dosed four weeks apart at weeks 0, 4, 8, and 12 of the 16 week study.', 'armGroupLabels': ['Vitamin D3 supplement']}, {'name': 'Inactive comparator', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Yanbin Dong, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Augusta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jennifer Pederson-White, DO', 'oldOrganization': 'Medical College of Georgia'}}}}