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:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT01477034
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-65 years;
* BMI ≥25 kg/m2;
* Plasma 25-OH-vitamin D between 7 and 20 ng/mL
* Weight stable to within 10 pounds for 6 months prior to entering the study, and within 30 pounds of their lifetime maximum weight (excluding pregnancy);
* Ability to be admitted for \~6.5 hours on three occasions to the FHCRC Prevention Center,
* Ability to provide informed written consent;
* Willingness to take vitamin D3 capsules daily for 6 months
Exclusion Criteria:
* Chronic disease such as thyroid disease, liver disease, or kidney disease;
* Diabetes mellitus, or fasting glucose \>125 mg/dL;
* Chronic inflammatory condition such as autoimmune disease or inflammatory bowel disease;
* Malabsorption syndromes (untreated celiac disease; condition after stomach or intestinal resection);
* Current or recent (within one month) chronic intake of medications likely to interfere with study endpoints \[(insulin, antidiabetics, anabolic steroids, glucocorticosteroids, statins, blood thinners (warfarin, aspirin), non-steroidal anti-inflammatory drugs (if daily)\];
* Current or recent (within 3 months) intake of vitamin D in excess of 600 IU/day;
* Anemia, recent history (within 3 months) of anemia; recent (within 3 months) blood donation; recent (within 3 months) participation in another study that involved blood draws; or plans to participate in other research that involves blood draws during the study period;
* Pregnancy in the last 6 months, plans to become pregnant during the study period, or current breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01477034
Study Brief:
Protocol Section:
NCT01477034