Folic Acid in Pediatric Inflammatory Bowel Disease

NCT03860012 | Unknown Phase 4 FDA Drug

• 1 other identifier: Folic acid in Peds IBD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

methotrexate; folic; acid

Outcome Measures

Primary Outcomes (2)

• Evaluation of Folate level

  Evaluation of Folate level

  at 6 months

• Evaluation of Folate level

  Evaluation of Folate level

  at 12 months

Study Arms (1)

Folic Acid 800 mcg once weekly

EXPERIMENTAL

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

Drug: Folic Acid

Interventions

Folic Acid DRUG

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

Also known as: Folate

Folic Acid 800 mcg once weekly

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• inflammatory bowel disease
• on methotrexate at appropriate dosing
• normal folate levels at onset of study
• treatment with folic acid
• ages 2-21 years

You may not qualify if:

• abnormal folate levels
• age \> 21 or less than 2

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead

Study Sites (1)

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (9)

• Bermejo F, Algaba A, Guerra I, Chaparro M, De-La-Poza G, Valer P, Piqueras B, Bermejo A, Garcia-Alonso J, Perez MJ, Gisbert JP. Should we monitor vitamin B12 and folate levels in Crohn's disease patients? Scand J Gastroenterol. 2013 Nov;48(11):1272-7. doi: 10.3109/00365521.2013.836752. Epub 2013 Sep 25.

  PMID: 24063425 RESULT

• Bermejo F, Algaba A, Guerra I, Gisbert JP. Response to letter: folate deficiency in Crohn's disease. Scand J Gastroenterol. 2014 Feb;49(2):255-6. doi: 10.3109/00365521.2013.869829. Epub 2013 Dec 16.

  PMID: 24328943 RESULT

• Dhir V, Sandhu A, Kaur J, Pinto B, Kumar P, Kaur P, Gupta N, Sood A, Sharma A, Sharma S. Comparison of two different folic acid doses with methotrexate--a randomized controlled trial (FOLVARI Study). Arthritis Res Ther. 2015 Jun 11;17(1):156. doi: 10.1186/s13075-015-0668-4.

  PMID: 26063325 RESULT

• Dupont-Lucas C, Grandjean-Blanchet C, Leduc B, Tripcovici M, Larocque C, Gervais F, Jantchou P, Amre D, Deslandres C. Prevalence and Risk Factors for Symptoms of Methotrexate Intolerance in Pediatric Inflammatory Bowel Disease. Inflamm Bowel Dis. 2017 Feb;23(2):298-303. doi: 10.1097/MIB.0000000000001014.

  PMID: 28107279 RESULT

• Heyman MB, Garnett EA, Shaikh N, Huen K, Jose FA, Harmatz P, Winter HS, Baldassano RN, Cohen SA, Gold BD, Kirschner BS, Ferry GD, Stege E, Holland N. Folate concentrations in pediatric patients with newly diagnosed inflammatory bowel disease. Am J Clin Nutr. 2009 Feb;89(2):545-50. doi: 10.3945/ajcn.2008.26576. Epub 2008 Dec 30.

  PMID: 19116333 RESULT

• Kaskel FJ, Bamgbola OF. Validation of a composite scoring scheme in the diagnosis of folate deficiency in a pediatric and adolescent dialysis cohort. J Ren Nutr. 2008 Sep;18(5):430-9. doi: 10.1053/j.jrn.2008.05.009.

  PMID: 18721738 RESULT

• Pan Y, Liu Y, Guo H, Jabir MS, Liu X, Cui W, Li D. Associations between Folate and Vitamin B12 Levels and Inflammatory Bowel Disease: A Meta-Analysis. Nutrients. 2017 Apr 13;9(4):382. doi: 10.3390/nu9040382.

  PMID: 28406440 RESULT

• Park JA, Shin HY. Influence of genetic polymorphisms in the folate pathway on toxicity after high-dose methotrexate treatment in pediatric osteosarcoma. Blood Res. 2016 Mar;51(1):50-7. doi: 10.5045/br.2016.51.1.50. Epub 2016 Mar 25.

  PMID: 27104192 RESULT

• Scaglione F, Panzavolta G. Folate, folic acid and 5-methyltetrahydrofolate are not the same thing. Xenobiotica. 2014 May;44(5):480-8. doi: 10.3109/00498254.2013.845705. Epub 2014 Feb 4.

  PMID: 24494987 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Heartburn

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tsega A Temtem, MD

  UTHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsega A Temtem, MD

CONTACT

901-287-7337; ttemtem@uthsc.edu

John R Whitworth, MD

CONTACT

901-287-7337; jwhitwor@uthsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: March 1, 2019
• Study Start: September 11, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 1, 2020
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)