Clinical trial NCT03860012: Folic Acid in Pediatric Inflammatory Bowel Disease
Official title: Evaluating the Efficacy of Weekly Folic Acid in Pediatric Inflammatory Bowel Disease Patients on Methotrexate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inflammatory Bowel Diseases
Keywords: methotrexate
folic
acid
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive 800mcg of supplemental folic acid per week.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Folate level
timeFrame: at 6 months
measure: Evaluation of Folate level
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: UTHSC
name: Tsega A Temtem, MD
role: PRINCIPAL_INVESTIGATOR
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