Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT00606957
Eligibility Criteria:
Inclusion Criteria:
* Nonsmoking men and women, ages 18-65
* Body mass index (BMI) ≥ 28 kg/m² and within 10% of maximum weight
* Serum 25(OH)D level ≤ 20 ng/ml
* Serum insulin level ≥ 7.2 mU/l
* Willingness to maintain current body weight for the duration of the study
* Willingness to maintain baseline lifestyle activities and routines for the duration of the study
* 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.)
* 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.
* If of childbearing potential, willingness to use highly effective contraception for the duration of the study.
Exclusion Criteria:
* Current tobacco smoking
* History of bleeding or coagulation disorders
* Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption
* History of diabetes, or diagnosed during screening OGTT
* Current treatment with hypertensive medications
* History of cardiovascular disease
* Renal disease, as evidenced by a serum creatinine above the upper limit of normal on more than one screening visit
* History of kidney stones
* History of chronic hepatitis, or liver enzymes (AST or ALT) more than 2.5 times the upper limit of normal
* Primary hyperparathyroidism or baseline hypercalcemia from any cause
* Current treatment with over-the-counter or prescription weight loss medications, such as orlistat or sibutramine
* History of bariatric surgery
* Current treatment with any cholesterol-lowering medications, such as statins, niacin, fibrates, or ezetimibe
* Blood pressure ≥ 145/90 after ten minutes of rest on more than one screen visit
* Hyperthyroidism or untreated hypothyroidism. Subjects with chronic, treated, stable hypothyroidism may be included in the study at the discretion of the Principal Investigator.
* Pregnancy, desired pregnancy, or lactation within the study period.
* HIV, Hepatitis B and C
* Medical conditions requiring daily calcium supplementation or antacid use
* 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)
* Subjects with known hypersensitivity to cholecalciferol
* Participation in an investigational drug study within one month of screening
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00606957
Study Brief:
Protocol Section:
NCT00606957