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

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 point of contact

Crystal Karakochuk, PhD, RD
604-710-8496
[email protected]
Brock Williams, MSc, RD
905-999-3710
[email protected]

Locations

1 Canada site

Age

2 to 19 Years

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Dietary Supplement

Compensation

Unknown

participation requirements

– Individuals with SCD aged 2-19 y attending British Columbia Children’s Hospital

– Individuals having received routine daily supplementation of folic acid for the prior
12-weeks

participation restrictions

– Individuals receiving a blood transfusion in the prior 12-weeks

– Individuals allergic to any components of the supplement (cellulose, methylcellulose,
magnesium stearate, and/or titanium dioxide)

– Individuals presenting with megaloblastic anemia in the prior 12-weeks

– Individuals with pulmonary, renal and/or cardiac complications (severe or recurrent
acute chest syndrome)

– Individuals routinely taking medications known to interfere with B vitamin metabolism
(chloramphenicol, methotrexate, metformin, sulfasalazine, phenobarbital, primidone,
triamterene, barbiturates)

– Individuals who are currently pregnant, planning to become pregnant in the next
9-months, or currently breastfeeding

– Individuals who have participated in a clinical research trial in the previous 30 days

– Individuals who have donated blood in the previous 30 days

– Individuals with unstable medical conditions or unstable laboratory results.

Locations

  • Vancouver, British Columbia, Canada, BC Children's Hospital, V6H 3N1 [Recruiting]
Last updated 2021-04-27