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Folic Acid in Pediatric Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860012
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Le Bonheur Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Drug: Folic Acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will receive 800mcg of supplemental folic acid per week.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Weekly Folic Acid in Pediatric Inflammatory Bowel Disease Patients on Methotrexate
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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.
Drug: Folic Acid
Patients on daily folic acid with a normal baseline folate level will be switched to once weekly dosing.
Other Name: Folate




Primary Outcome Measures :
  1. Evaluation of Folate level [ Time Frame: at 6 months ]
    Evaluation of Folate level

  2. Evaluation of Folate level [ Time Frame: at 12 months ]
    Evaluation of Folate level



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860012


Contacts
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Contact: Tsega A Temtem, MD 901-287-7337 ttemtem@uthsc.edu
Contact: John R Whitworth, MD 901-287-7337 jwhitwor@uthsc.edu

Locations
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United States, Tennessee
LeBonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Tsega A Temtem, MD    901-287-7489    ttemtem@uthsc.edu   
Contact: John R Whitworth, MD    901-287-4017    jwhitwor@uthsc.edu   
Sponsors and Collaborators
Le Bonheur Children's Hospital
Investigators
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Principal Investigator: Tsega A Temtem, MD UTHSC
  Study Documents (Full-Text)

Documents provided by Le Bonheur Children's Hospital:
Study Protocol  [PDF] May 30, 2018

Publications of Results:

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Responsible Party: Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT03860012    
Other Study ID Numbers: Folic acid in Peds IBD
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Le Bonheur Children's Hospital:
methotrexate
folic
acid
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Folic Acid
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs