Folic Acid in Pediatric Inflammatory Bowel Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 2 - 21 |
| Updated: | 3/3/2019 |
| Start Date: | September 11, 2018 |
| End Date: | May 1, 2020 |
| Contact: | Tsega A Temtem, MD |
| Email: | ttemtem@uthsc.edu |
| Phone: | 901-287-7337 |
Evaluating the Efficacy of Weekly Folic Acid in Pediatric Inflammatory Bowel Disease Patients on Methotrexate
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.
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.
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.
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.
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
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