Recruiting

Folic Acid

Sponsor:

Le Bonheur Children's Hospital

Code:

NCT03860012

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

Interventions

Folic Acid

Study Details

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.

Conditions

Inflammatory Bowel Diseases

Study ID

NCT03860012

Start date

Sep 11, 2018

Status verified date

Feb, 2019

Completion date

May 1, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Folic Acid 800 mcg once weekly

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

Interventions

Folic Acid

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

Primary outcome measure

  • Evaluation of Folate level [ Time Frame: at 6 months ]
  • Evaluation of Folate level [ Time Frame: at 12 months ]

Central Contacts and Locations

Central contacts

Locations

LeBonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

More Information

Sponsor

Le Bonheur Children's Hospital

Last update posted

Mar 1, 2019

Last verified

Feb, 2019

Keywords

  • methotrexate
  • folic
  • acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Le Bonheur Children's Hospital on 2019-03-01.