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Folic acid supplementation in children with sickle cell disease: study protocol for a double-blind randomized

Brock A Williams1,2, Heather McCartney3, Erin Adams4

  • 1Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, 2205 East Mall, Vancouver, British Columbia, V6T 1Z4, Canada.

Trials
|July 1, 2020
PubMed

Insights

This study investigates high-dose folic acid supplementation in children with sickle cell disease (SCD). Findings will help determine optimal folate intake for improved nutritional status in pediatric SCD patients.

Area of Science:

  • Pediatric Hematology
  • Nutritional Science
  • Genetic Disorders

Background:

  • Sickle cell disease (SCD) increases folate requirements due to high red blood cell (RBC) turnover.
  • Standard high-dose folic acid (1-5 mg/d) supplementation is recommended for children with SCD.
  • Concerns exist regarding high folic acid doses due to mandatory food fortification and potential risks of unmetabolized folic acid (UMFA).

Purpose of the Study:

  • To determine the efficacy of high-dose folic acid supplementation in children with SCD.
  • To assess alterations in folate metabolism, including UMFA levels, during folic acid supplementation.
  • To inform current clinical practice and improve nutritional status in pediatric SCD patients.

Main Methods:

  • A double-blind, randomized controlled cross-over trial involving 36 children with SCD (aged 2-19 years).
  • Participants received 1 mg/d folic acid or placebo for 12 weeks, followed by a 12-week washout and then switched treatments.
  • Measurements included total folate, folate forms (UMFA), metabolites, and clinical outcomes at baseline and post-treatment.

Main Results:

  • This section is to be filled once the study results are available.
  • The study is designed to provide robust data on folate status and metabolism in pediatric SCD.
  • Primary outcomes focus on RBC folate concentrations and UMFA levels.

Conclusions:

  • This trial is the first rigorously designed study to evaluate high-dose folic acid in children with SCD.
  • Results will provide critical insights into the necessity and safety of current folic acid supplementation guidelines.
  • The ultimate goal is to optimize nutritional management and improve health outcomes for children with sickle cell disease.
Abstract

Keywords:
Folic acidMicronutrient supplementationNutritionPediatricsRandomized control trialSickle cell disease

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