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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT00621257
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of inflammatory bowel disease
* serum 25OHD level ≤ 20 ng/mL (Treatment Trial)
* serum 25OHD level \> 20 ng/mL (Maintenance Trial)
Exclusion Criteria:
* Patients unable to take medications by mouth, pregnant, with liver/kidney failure, receiving anticonvulsant medications (specifically, phenobarbital, carbamazepine and phenytoin, since they lead to increased vitamin D metabolism through hepatic induction of the cytochrome P450 (CYP450) hydroxylase enzymes), regularly attending a tanning salon (once weekly or more), currently being treated for hypovitaminosis D with therapeutic doses of vitamin D (\> 800 IU per day) and unwilling to discontinue this regimen.
* patients on growth hormone, anabolic steroid hormones, calcitonin, bisphosphonates (Maintenance Trial only)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT00621257
Study Brief:
Protocol Section:
NCT00621257