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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT01546103
Eligibility Criteria:
Inclusion Criteria:
* African American
* Obese \[body mass index (BMI) greater than or equal to 95th percentile for age and sex\]
* Pubertal (Tanner Stage greater than 1)
* 25OHD less than 20 ng/mL (for treatment phase); if 25OHD is greater than or equal to 20 ng/mL, only baseline data will be obtained.
* Committed to adherence to supplementation and study completion
Exclusion Criteria:
* Pregnancy
* Chronic medical conditions or medications use that can affect growth, nutrition, bone health, vitamin D metabolism, glucose, or insulin sensitivity
* Known history of hypercalcemia or hypercalciuria
* Non-English speaking, as assessments are available only in English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT01546103
Study Brief:
Protocol Section:
NCT01546103