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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02168660
Eligibility Criteria:
Inclusion Criteria:
* age 6-17 years
* BMI \> 95% for age
* serum 25-OH D level \< or + to 25 ng/mL
Exclusion Criteria:
* BMI \< 95% for age
* serum 25-OH D level \> 25 ng/mL
* current Vitamin D supplementation \> 400 IU/day
* anti-convulsant therapy, anti-hypertensive therapy, lipid lowering medication
* any medications that affect glucose metabolism (e.g., metformin, insulin)
* daily glucocorticoid therapy
* diabetes
* any disorders of bone or calcium metabolism
* hepatic or renal disease
* any malabsorptive disorder
* baseline serum Calcium \> 11 ng/dL (\> 2 SD above the mean)
* any genetic disorder that predisposes to obesity (e.g., Prader Willi
* hypothalamic obesity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT02168660
Study Brief:
Protocol Section:
NCT02168660