title: Folic acid supplementation on homocysteine levels in children taking antiepileptic drugs: A randomized controlled trial.
abstract: OBJECTIVE
  To assess the level of homocysteine (tHcy) in children taking AEDs and to study whether daily oral supplementation of folic acid for 1 month will reduce the tHcy level.
  
  
  METHODS
  This was a double-blinded, randomized control trial conducted in Institute of Maternal and Child Health, Kozhikode, India. Totally 60 children were recruited and of them, 48 were enrolled. Of these children, 32 were assigned to the experimental group and 16 to the control group. Baseline data collection and tHcy estimation were done. One mg folic acid tablets were given to the experimental group and placebo tablets to the control group for 30 days. tHcy levels were re-estimated after 1 month follow-up. Statistical significance was tested by χ(2) test, and paired and unpaired t-tests, as appropriate. Correlation was tested by Pearson correlation test and P value less than 0.05 was taken as the cut-off for statistical significance.
  
  
  RESULTS
  Baseline plasma tHcy concentrations in both groups were comparable [11.90 (6.3) and 13.02 (2.4) μmol/l, respectively]. During the follow-up period, no increase in seizure episodes or no serious adverse reactions were noticed in either group. The reduction of tHcy in the experimental group was 1.92 μmol/l (P = 0.04) and in the control group, there was an increase of 1.05 μmol/l (P = 0.16).
  
  
  CONCLUSIONS
  In children on AED treatment, folic acid supplementation may reduce tHcy level and thus reduce CVD risk.
authors.affiliation: Department of Pharmacology, Government Medical College, Calicut, Kerala, India.
authors.forename: Mathummal Cherumanalil
authors.initials: MC
authors.lastname: Jeeja
authors.affiliation: Department of Community Medicine, Government Medical College, Calicut, Kerala, India.
authors.forename: Thayyil
authors.initials: T
authors.lastname: Jayakrishnan
authors.affiliation: Department of Pharmacology, Government Medical College, Calicut, Kerala, India.
authors.forename: Puthiya Veettil
authors.initials: PV
authors.lastname: Narayanan
authors.affiliation: Department of Paediatrics, Government Medical College, Calicut, Kerala, India.
authors.forename: Mathur Sreedharan Vinod
authors.initials: MS
authors.lastname: Kumar
authors.affiliation: Division of Surgical Oncology, Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA.
authors.forename: Thayyil
authors.initials: T
authors.lastname: Thejus
authors.affiliation: Department of Nuclear Medicine, Government Medical College, Calicut, Kerala, India.
authors.forename: Vadakay Purayil
authors.initials: VP
authors.lastname: Anilakumari
keywords: Antiepileptic drugs; cardiovascular disease risk factors; folic acid supplementation; hyperhomocysteinemia