- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860012
Folic Acid in Pediatric Inflammatory Bowel Disease
Evaluating the Efficacy of Weekly Folic Acid in Pediatric Inflammatory Bowel Disease Patients on Methotrexate
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Tsega A Temtem, MD
- Phone Number: 901-287-7337
- Email: ttemtem@uthsc.edu
Study Contact Backup
- Name: John R Whitworth, MD
- Phone Number: 901-287-7337
- Email: jwhitwor@uthsc.edu
Study Locations
-
-
Tennessee
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Memphis, Tennessee, United States, 38103
- Recruiting
- LeBonheur Children's Hospital
-
Contact:
- Tsega A Temtem, MD
- Phone Number: 901-287-7489
- Email: ttemtem@uthsc.edu
-
Contact:
- John R Whitworth, MD
- Phone Number: 901-287-4017
- Email: jwhitwor@uthsc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- inflammatory bowel disease
- on methotrexate at appropriate dosing
- normal folate levels at onset of study
- treatment with folic acid
- ages 2-21 years
Exclusion Criteria:
- abnormal folate levels
- age > 21 or less than 2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Patients on daily folic acid with a normal baseline folate level will be switched to once weekly dosing.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Folate level
Time Frame: at 6 months
|
Evaluation of Folate level
|
at 6 months
|
Evaluation of Folate level
Time Frame: at 12 months
|
Evaluation of Folate level
|
at 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tsega A Temtem, MD, UTHSC
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Folic acid in Peds IBD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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