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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT02076750
Eligibility Criteria:
Inclusion Criteria:
1. Established diagnosis of inflammatory bowel disease made by a pediatric gastroenterologist and confirmed by histopathology
2. Serum 25-OH vitamin D level \<30 ng/mL at time of enrollment.
3. Age 8-21 years
4. Weight \> 20 kg
5. Parent, guardian, or subject (where applicable) able to give consent/assent
Exclusion Criteria:
1. Inability to ingest oral vitamin D3 capsules
2. Presence of known hepatobiliary disease
3. Presence of known kidney disease or history of renal stones
4. Use of systemic steroids within 60 days prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT02076750
Study Brief:
Protocol Section:
NCT02076750