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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02362269
Eligibility Criteria:
Inclusion Criteria:
* Healthy, community-dwelling postmenopausal woman of self-reported European (Madison site) or African (Milwaukee site) descent
* Able and willing to sign informed consent
* Baseline serum 25(OH)D concentration of 10.0-29.9 ng/mL
* Willing to not alter the amount of their baseline vitamin D supplementation during the course of this study
* Willing to use sunscreen (SPF ≥15) when sun exposure of \>15 minutes is expected during the months of May through September
Exclusion Criteria:
* Diagnosis of kidney or liver disease (organs that metabolize vitamin D)
* Current hypercalcemia (serum calcium ≥ 10.5 mg/dL) or other disorders that may affect vitamin D metabolism and predispose to hypercalcemia, i.e., sarcoidosis, active tuberculosis or other granulomatous disease.
* Other chronic diseases or conditions potentially affecting vitamin D metabolism or absorption (inflammatory bowel disease, cystic fibrosis, ulcerative colitis, and malabsorptive surgery)
* History of nephrolithiasis
* Current use of medications that affect vitamin D metabolism (glucocorticoids, anticonvulsants, antifungals, and HIV/AIDS medications)
* History of any form of cancer within the past two years with the exception of basal or squamous cell skin lesions, in situ tumors or thyroid cancer
* Terminal illness/on hospice
* Severe end-organ disease (e.g., cardiovascular, pulmonary, etc.), which may limit the ability to complete the study
* Treatment with high dose vitamin D (≥50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening; current use of multiple vitamins and other vitamin D supplements will be allowed.
* Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer from May through September
* Planned trips/vacations likely to be associated with substantial amounts of sun exposure during the course of the study (i.e., more than 500 miles south of Madison/Milwaukee)
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT02362269
Study Brief:
Protocol Section:
NCT02362269