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 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT01058720
Eligibility Criteria:
Inclusion criteria:
* Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.
Exclusion Criteria:
* Subjects with 25 (OH)- D levels \>80 ng/mL
* Serum calcium \>10.8 mg/dL
* Serum phosphorus \> 5.5 mg/dl
* Pregnancy or nursing
* Current cancer
* Patients on multivitamin supplementation
* Dietary calcium intake exceeding 1500 mg/day
* Hepatic or renal disorders
* Type 1 or Type 2 diabetes mellitus
* Those receiving insulin, metformin, or oral hypoglycemic medications
* Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT01058720
Study Brief:
Protocol Section:
NCT01058720