October, 10 2019

Folic Acid Supplementation in Children With Sickle-Cell Disease: A Randomized Double-Blind Cross-Over Trial

Age

2 to 19 Years

Phase

N/A

About the study

Folic acid supplementation (1mg/d) is the standard recommendation for Canadian children with
Sickle cell disease (SCD), even though it can provide up to six times the recommended intake
amount for healthy children. There is growing concern that too much folic acid can be
detrimental to health as high folate levels and circulating unmetabolized folic acid (UMFA),
which occurs in blood with doses of folic acid as low as 0.2mg/d, have been associated with
accelerated growth of some pre-cancerous cells, and altered DNA methylation and gene
expression.

To inform the efficacy and potential harm of high-dose folic acid supplementation in Canadian
children with SCD, a double-blind randomized controlled cross-over trial is proposed.
Children with SCD (n=36, aged 2-19 y) will be recruited from BC Children’s Hospital and
randomized to initially receive 1 mg/d folic acid or a placebo for 12-weeks (wk). After a
12-wk washout period, treatments will be reversed.

Study Type

Interventional

Phase

N/A

Age

2 to 19 Years

Gender

All

Inclusion Criteria

– Diagnosis of sickle cell disease

– Aged 2-19 years

– Receive medical treatment at BC Children’s Hospital

Exclusion Criteria

– Blood transfusion in the last 12 weeks (84 days)

Interventions

  • Dietary Supplement

Outcome measures

  • Red Blood Cell Folate Concentration

Contact Research Team

  • Crystal Karakochuk, PhD, RD
    604-710-8496
  • Brock Williams, MSc, RD
    905-999-3710

More info

View on ClinicalTrials
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