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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT02174718
Eligibility Criteria:
Inclusion Criteria:
* Healthy, community-dwelling ambulatory adults
* Able and willing to sign informed consent
* Age 18 to 75 years
* Baseline serum 25OHD concentration \> 10 ng/mL and \< 50 ng/mL
* Not pregnant
* Willing to not alter the amount of their baseline vitamin D supplementation during the course of this study
* Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected
Exclusion Criteria:
* Current hypercalcemia (serum calcium \> 10.5 mg/dl) or untreated primary hyperparathyroidism
* History of nephrolithiasis
* Baseline 24-hour urine calcium \> 250 mg (female) or 300 mg (male)
* Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis
* History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma
* Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of ≤ 35 ml/minute
* Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study
* Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital
* Known cutaneous sensitivity/allergy to tape or adhesives
* Known skin diseases, e.g., psoriasis, pemphigus, etc, which might alter transdermal vitamin D absorption
* 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
* Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer
* Planned trips/vacations likely to be associated with substantial amounts of sun exposure during the course of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02174718
Study Brief:
Protocol Section:
NCT02174718