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Folic Acid in Pediatric Inflammatory Bowel Disease

Evaluating the Efficacy of Weekly Folic Acid in Pediatric Inflammatory Bowel Disease Patients on Methotrexate

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03860012
Enrollment
100
Registered
2019-03-01
Start date
2018-09-11
Completion date
2020-05-01
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

methotrexate, folic, acid

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 deficiency, so the current recommendation is to give daily folic acid supplementation while on methotrexate. Standard of care is to administer folic acid supplements daily. Patient compliance with daily folic acid is often suboptimal. The rationale is that weekly folic acid supplementation is as efficacious as daily dosing, and less frequent dosing likely will help improve patient compliance. The optimal dosing schedule of folate supplementation in relation to methotrexate is not known and there are not many research studies that have studied changing dosing of folate supplementation. One particular research study examined the effect of different dosing of folic acid supplements in patients with rheumatoid arthritis taking methotrexate. The study showed that folic acid at two different doses per week (5 mg low dose vs 27.5 mg high dose) did not effect the efficacy of methotrexate therapy, and patients who were on either folic acid supplementation had lower toxicity scores compared to patients not on folic acid supplementation. This study shows that folic acid dosed once per week can be useful in preventing methotrexate toxicity for rheumatoid arthritis patients. There were no studies that could be found that have studied this correlation for pediatric inflammatory bowel disease. Based on this current study, once weekly dosing of folic acid in IBD patients on methotrexate has the potential to be as efficacious as daily dosing.

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 study population is pediatric patients (ages 2-21) with inflammatory bowel disease on methotrexate who are receiving supplemental folic acid. The current standard of care is to administer folic acid supplements on a daily basis. This will be a prospective study involving pediatric IBD patients on methotrexate. Each patient's baseline folate levels and other routine labs at enrollment (time zero) will function as their control at the conclusion of the study. Doses will be standardized prior to study initiation. All patients will receive 800mcg of supplemental folic acid per week. IBD patients are typically evaluated and have lab draws every 6 months. For our study, labs will be obtained as routine labs (CBC, CMP) and a baseline folate level at the time of enrollment. Once these labs are obtained, patients with normal folate levels will qualify for inclusion in the study. They will be started on once weekly folate dosing. During the course of the study, if patients develop low folate levels, they will be removed from the study and placed back on daily doses of folate.

Interventions

DRUGFolic Acid

Patients on daily folic acid with a normal baseline folate level will be switched to once weekly dosing.

Sponsors

Le Bonheur Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

All patients will receive 800mcg of supplemental folic acid per week.

Eligibility

Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

1. inflammatory bowel disease 2. on methotrexate at appropriate dosing 3. normal folate levels at onset of study 4. treatment with folic acid 5. ages 2-21 years

Exclusion criteria

1. abnormal folate levels 2. age \> 21 or less than 2

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Folate levelat 6 monthsEvaluation of Folate level

Countries

United States

Contacts

Primary ContactTsega A Temtem, MD
ttemtem@uthsc.edu901-287-7337
Backup ContactJohn R Whitworth, MD
jwhitwor@uthsc.edu901-287-7337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026