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Folic Acid 800 mcg once weekly for Inflammatory Bowel Disease

Phase 4
Waitlist Available
Led By Tsega A Temtem, MD
Research Sponsored by Le Bonheur Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights

Study 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.

Eligible Conditions
  • Inflammatory Bowel Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of Folate level

Trial Design

1Treatment groups
Experimental Treatment
Group I: Folic Acid 800 mcg once weeklyExperimental Treatment1 Intervention
Patients on daily folic acid with a normal baseline folate level will be switched to once weekly dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folic acid
FDA approved

Find a Location

Who is running the clinical trial?

Le Bonheur Children's HospitalLead Sponsor
27 Previous Clinical Trials
5,020,949 Total Patients Enrolled
Tsega A Temtem, MDPrincipal InvestigatorUTHSC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~15 spots leftby Apr 2025