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

The objective of this study is to determine efficacy of, and alterations in folate metabolism from high-dose folic acid in children with SCD during periods of folic acid supplementation versus no supplementation.MethodsIn this double-blind randomized controlled cross-over trial, children with SCD (n = 36, aged 2–19 years) will be randomized to either receive 1 mg/d folic acid, the current standard of care, or a placebo for 12 weeks. After a 12-week washout period, treatments will be reversed. Total folate concentrations (serum and RBC), different folate forms (including UMFA), folate -related metabolites, and clinical outcomes will be measured at baseline and after treatment periods. The sum of the values measured in the two periods will be calculated for each subject and compared across the two sequence groups by means of a test for independent samples for the primary (RBC fola te concentrations) and secondary (UMFA) outcomes. Dietary intake will be measured at the beginning of each study period.DiscussionAs the first rigorously designed clinical trial in children with SCD, this trial will inform and assess current clinical practice, with the ultimate goal of improving nutritional status of children with SCD.Trial registrationClinicalTrials.govNCT04011345. Registered on July 8, 2019
Source: Trials - Category: Research Source Type: clinical trials