PMID- 36228310 OWN - NLM STAT- MEDLINE DCOM- 20221017 LR - 20221120 IS - 1465-3664 (Electronic) IS - 0142-6338 (Linking) VI - 68 IP - 6 DP - 2022 Oct 6 TI - Optimum dose of oral folic acid supplementation in transfusion-dependent thalassemia: a randomized controlled trial. LID - fmac087 [pii] LID - 10.1093/tropej/fmac087 [doi] AB - AIM AND OBJECTIVES: We compared the effect of different doses of oral folic acid (FA) supplementation (5 mg/day vs. 2.5 mg/day vs. 5 mg/week) on the proportion of children with folate excess (serum folate >20 ng/ml) and plasma homocysteine (Hcys) excess (>15 micromol/l) in transfusion-dependent thalassemia (TDT). MATERIALS AND METHODS: Children with TDT aged 5-18 years received oral FA in doses of 5 mg/day (Group 1), 2.5 mg/day (Group 2) and 5 mg/week (Group 3) for 9 months, after a wash-off period of 8 weeks. Folate levels (Serum and RBC) and plasma Hcys levels were measured after the therapy. RESULTS: Ninety children were randomized to receive one of the three interventions (30 per group). After wash-off period, the median serum folate levels were significantly lower and five children developed folate deficiency; the median [interquartile range (IQR)] serum folate levels (ng/dl) were comparable in the three groups [Group 1: 6.5 (3.3-14.2), Group 2: 5.1 (2.6-10.5) and Group 3: 4.8 (3.4-10.0)]. After 9 months of intervention, the median (IQR) serum folate levels (ng/ml) were comparable in all participants [Group 1: 18.0 (6.5-28), Group 2: 13.5 (6.4-24.5) and Group 3: 9.7 (5.3-22.5); p = 0.11]. Proportion of children with serum folate excess was 40%, 26.7% and 26.7% in Group 1, Group 2 and Group 3 (p = 0.48). Proportion of children with RBC folate excess was 92%, 86.7% and 86.7% in Group 1, Group 2 and Group 3 (p = 0.79). Hyperhomocysteinemia was seen in eight children with no significant difference between median Hcys levels in the groups (p = 0.75). CONCLUSION: Folic acid supplementation is recommended in TDT with 5 mg weekly dose being adequate. CI - (c) The Author(s) [2022]. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com. FAU - Agrawal, Titiksha AU - Agrawal T AUID- ORCID: 0000-0003-3538-8757 AD - Department of Pediatrics, University College of Medical Sciences, Delhi 110095, India. FAU - Dewan, Pooja AU - Dewan P AUID- ORCID: 0000-0002-7373-5679 AD - Department of Pediatrics, University College of Medical Sciences, Delhi 110095, India. FAU - Gomber, Sunil AU - Gomber S AD - Department of Pediatrics, University College of Medical Sciences, Delhi 110095, India. FAU - Agarwal, Rachna AU - Agarwal R AD - Department of Neurochemistry, Institute of Human Behaviour & Allied Sciences (IHBAS), Delhi 110095, India. FAU - Sharma, Sangeeta AU - Sharma S AD - Department of Neuropsychopharmacology, Institute of Human Behaviour & Allied Sciences (IHBAS), Delhi 110095, India. FAU - Kotru, Mrinalini AU - Kotru M AD - Department of Pathology, University College of Medical Sciences, Delhi 110095, India. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - J Trop Pediatr JT - Journal of tropical pediatrics JID - 8010948 RN - 0LVT1QZ0BA (Homocysteine) RN - 935E97BOY8 (Folic Acid) SB - IM MH - Child MH - Dietary Supplements MH - *Folic Acid MH - Homocysteine MH - Humans MH - *Thalassemia/drug therapy OTO - NOTNLM OT - child OT - folate OT - hemolytic anemia OT - homocysteine EDAT- 2022/10/14 06:00 MHDA- 2022/10/18 06:00 CRDT- 2022/10/13 17:12 PHST- 2022/10/13 17:12 [entrez] PHST- 2022/10/14 06:00 [pubmed] PHST- 2022/10/18 06:00 [medline] AID - 6760805 [pii] AID - 10.1093/tropej/fmac087 [doi] PST - ppublish SO - J Trop Pediatr. 2022 Oct 6;68(6):fmac087. doi: 10.1093/tropej/fmac087.