Status:
UNKNOWN
Folic Acid in Pediatric Inflammatory Bowel Disease
Lead Sponsor:
Le Bonheur Children's Hospital
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
2-21 years
Phase:
PHASE4
Brief Summary
Inflammatory bowel disease often requires immunomodulators, such as methotrexate, to maintain disease remission. This medication is administered as one dose weekly. Methotrexate can cause folic acid d...
Detailed Description
The purpose of this study is to evaluate the efficacy of once weekly supplemental folic acid dosing compared to daily dosing in patients with inflammatory bowel disease (IBD) on methotrexate. The stu...
Eligibility Criteria
Inclusion
- inflammatory bowel disease
- on methotrexate at appropriate dosing
- normal folate levels at onset of study
- treatment with folic acid
- ages 2-21 years
Exclusion
- abnormal folate levels
- age \> 21 or less than 2
Key Trial Info
Start Date :
September 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03860012
Start Date
September 11 2018
End Date
May 1 2020
Last Update
March 1 2019
Active Locations (1)
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1
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103