Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-04 @ 6:11 PM
Study NCT ID:
NCT00606957
Status:
COMPLETED
Last Update Posted:
2011-10-13
First Post:
2008-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin D Repletion on Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-12', 'studyFirstSubmitDate': '2008-01-22', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is change in insulin sensitivity over time, as measured by the glucose clamp, HOMA and OGTT.', 'timeFrame': '14 weeks'}]}, 'conditionsModule': {'keywords': ['Obesity', 'Metabolism'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "The reason for doing this study is to learn whether raising a person's vitamin D level from below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D is well known to be an important vitamin for the development and maintenance of bones. Recently, scientists have learned that vitamin D may have a role in the prevention of cancer, diabetes, and autoimmune diseases. The investigators are specifically interested in studying this question in the overweight/obese population as they are at greater risk for both vitamin D deficiency and impaired ability to metabolize sugar (glucose intolerance).\n\nPrimary Hypotheses:\n\nVitamin D repletion (increasing the serum 25(OH)D level from ≤ 20 ng/ml to ≥ 30 ng/ml) will improve insulin sensitivity in individuals who are overweight/obese and insulin resistant.\n\nSecondary Hypotheses:\n\n1.Vitamin D repletion will improve biomarkers of cardiovascular risk and inflammation (directly altering macrophage cytokine production and/or indirectly as a result of improvement in insulin sensitivity.) 2.30,000 IU (0.25 mg) weekly of cholecalciferol (vitamin D3) will raise serum 25(OH)D levels from ≤ 20 ng/ml to ≥ 30 ng/ml overweight/obese population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nonsmoking men and women, ages 18-65\n* Body mass index (BMI) ≥ 28 kg/m² and within 10% of maximum weight\n* Serum 25(OH)D level ≤ 20 ng/ml\n* Serum insulin level ≥ 7.2 mU/l\n* Willingness to maintain current body weight for the duration of the study\n* Willingness to maintain baseline lifestyle activities and routines for the duration of the study\n* Willingness to avoid the use of non-steroidal anti-inflammatory drugs (NSAIDS), including low-dose daily aspirin, for at least ten days prior to each admission (due to the potential effects of these agents on inflammatory markers.)\n* Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study, with the exception of a basic multivitamin supplement.\n* If of childbearing potential, willingness to use highly effective contraception for the duration of the study.\n\nExclusion Criteria:\n\n* Current tobacco smoking\n* History of bleeding or coagulation disorders\n* Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption\n* History of diabetes, or diagnosed during screening OGTT\n* Current treatment with hypertensive medications\n* History of cardiovascular disease\n* Renal disease, as evidenced by a serum creatinine above the upper limit of normal on more than one screening visit\n* History of kidney stones\n* History of chronic hepatitis, or liver enzymes (AST or ALT) more than 2.5 times the upper limit of normal\n* Primary hyperparathyroidism or baseline hypercalcemia from any cause\n* Current treatment with over-the-counter or prescription weight loss medications, such as orlistat or sibutramine\n* History of bariatric surgery\n* Current treatment with any cholesterol-lowering medications, such as statins, niacin, fibrates, or ezetimibe\n* Blood pressure ≥ 145/90 after ten minutes of rest on more than one screen visit\n* Hyperthyroidism or untreated hypothyroidism. Subjects with chronic, treated, stable hypothyroidism may be included in the study at the discretion of the Principal Investigator.\n* Pregnancy, desired pregnancy, or lactation within the study period.\n* HIV, Hepatitis B and C\n* Medical conditions requiring daily calcium supplementation or antacid use\n* Use of medications known to interact with calcium or vitamin D metabolism (bisphosphonates, corticosteroids, thiazide diuretics, cholestyramine, colestipol, mineral oil, phenytoin, barbituates, dititalis glycosides, antacids)\n* Subjects with known hypersensitivity to cholecalciferol\n* Participation in an investigational drug study within one month of screening\n* History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study'}, 'identificationModule': {'nctId': 'NCT00606957', 'briefTitle': 'The Effect of Vitamin D Repletion on Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Rockefeller University'}, 'officialTitle': 'The Effect of Vitamin D Repletion on Insulin Resistance', 'orgStudyIdInfo': {'id': 'RUH IRB# AGR-0623'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vitamin D3 (cholecalciferol)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D will be taken orally, 10,000 IU (0.25 mg) three times per week.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Rockefeller University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Allegra Grossman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Rockefeller University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockefeller University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Allegra Grossman, MD', 'oldOrganization': 'The Rockefeller University'}}}}