NCT04011345

Folic Acid Supplementation in Children With Sickle Cell Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 2 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Blood samples will be collected at baseline and 12-wk of each treatment period (weeks 12, 24, and 36). Serum and RBC concentrations of total folate, different folate forms and clinical outcomes will be measured at baseline and after each treatment period. Dietary folate intake will be assessed at baseline. The objective of this study is to determine efficacy and potential harm of folic acid supplementation, versus no supplementation, in Canadian children with sickle cell disease. It is hypothesized that: (1) there will be no difference in mean RBC folate concentrations across folic acid and placebo groups after 12-wk, (2) none of the participants will have folate deficiency, and (3) compared to periods of no supplementation, during periods of high-dose folic acid supplementation participants will show no difference in clinical outcomes, but have higher plasma unmetabolized folic acid concentrations. Significance: There is a need to determine if the current clinical practice of high-dose folic acid supplementation is efficacious, and warranted.

Conditions

• Anemia, Sickle Cell

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Folic Acid Supplement	1 milligram folic acid
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2020-11-23
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2019-07-08
• Last updated: 2023-08-24

Locations

1 site across 1 country: Canada