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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT01797302
Eligibility Criteria:
Inclusion Criteria:
* Eligible subjects will be 10 to 18 years of age;
* obese or overweight (BMI ≥85th %tile);
* otherwise healthy, and
* have a serum 25(OH)D concentration \<20 ng/mL
Children taking multivitamins should be able to hold off their multivitamins during the course of the study.
Exclusion Criteria:
Children will be excluded if they
* (a) have hepatic or renal disease, metabolic rickets, malabsorptive disorders, primary hyperparathyroidism, hyperthyroidism, or other chronic disorders that could affect vitamin D metabolism;
* (b) are receiving treatment with anticonvulsants, systemic glucocorticoids, pharmacologic doses of vitamin D (≥1000 IU of vitamin D2 or D3 daily), antihypertensives, vasoactive drugs, antilipidemics, metformin, antipsychotics, or other oral insulin regulators;
* (c) have cholelithiasis or urolithiasis;
* (d) have type 1 or type 2 diabetes; or
* (e) have a condition or underlying abnormality that could compromise the safety of the subject.
Post-menarchial girls with a positive pregnancy test at randomization, or subjects found during the screening phase to have hypercalcemia (serum calcium \>10.8 mg/dL) or significant fasting hyperglycemia (fasting blood glucose ≥ 125 mg/dL) will also be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT01797302
Study Brief:
Protocol Section:
NCT01797302