title: Effect of physiological doses of oral vitamin B12 on plasma homocysteine: a randomized, placebo-controlled, double-blind trial in India.
abstract: OBJECTIVE
  Vitamin B(12) (B(12)) deficiency is common in Indians and a major contributor to hyperhomocysteinemia, which may influence fetal growth, risk of type II diabetes and cardiovascular disease. The purpose of this paper was to study the effect of physiological doses of B(12) and folic acid on plasma total homocysteine (tHcy) concentration.
  
  
  METHODS
  A cluster randomized, placebo-controlled, double-blind, 2 x 3 factorial trial, using the family as the randomization unit. B(12) was given as 2 or 10 microg capsules, with or without 200 microg folic acid, forming six groups (B(0)F(0), B(2)F(0), B(10)F(0), B(0)F(200), B(2)F(200) and B(10)F(200)). Plasma tHcy concentration was measured before and after 4 and 12 months of supplementation.
  
  
  RESULTS
  From 119 families in the Pune Maternal Nutrition Study, 300 individuals were randomized. There was no interaction between B(12) and folic acid (P=0.14) in relation to tHcy concentration change and their effects were analyzed separately: B(0) vs. B(2) vs. B(10); and F(0) vs. F(200). At 12 months, tHcy concentration reduced by a mean 5.9 (95% CI: -7.8, -4.1) micromol/l in B(2), and by 7.1 (95% CI: -8.9, -5.4) micromol/l in B(10), compared to nonsignificant rise of 1.2 (95% CI: -0.5, 2.9) micromol/l in B(0). B(2) and B(10) did not differ significantly. In F(200), tHcy concentration decreased by 4.8 (95% CI: -6.3, -3.3) micromol/l compared to 2.8 (95% CI: -4.3, -1.2) micromol/l in F(0).
  
  
  CONCLUSIONS
  Daily oral supplementation with physiological doses of B(12) is an effective community intervention to reduce tHcy. Folic acid (200 microg per day) showed no additional benefit, neither had any unfavorable effects.
authors.affiliation: Diabetes Unit, King Edward Memorial Hospital Research Centre, Pune, Maharashtra, India.
authors.forename: U S
authors.initials: US
authors.lastname: Deshmukh
authors.forename: C V
authors.initials: CV
authors.lastname: Joglekar
authors.forename: H G
authors.initials: HG
authors.lastname: Lubree
authors.forename: L V
authors.initials: LV
authors.lastname: Ramdas
authors.forename: D S
authors.initials: DS
authors.lastname: Bhat
authors.forename: S S
authors.initials: SS
authors.lastname: Naik
authors.forename: P S
authors.initials: PS
authors.lastname: Hardikar
authors.forename: D A
authors.initials: DA
authors.lastname: Raut
authors.forename: T B
authors.initials: TB
authors.lastname: Konde
authors.forename: A K
authors.initials: AK
authors.lastname: Wills
authors.forename: A A
authors.initials: AA
authors.lastname: Jackson
authors.forename: H
authors.initials: H
authors.lastname: Refsum
authors.forename: A S
authors.initials: AS
authors.lastname: Nanivadekar
authors.forename: C H
authors.initials: CH
authors.lastname: Fall
authors.forename: C S
authors.initials: CS
authors.lastname: Yajnik
mesh_terms: D000328:Adult; D002648:Child; D019587:Dietary Supplements; D004311:Double-Blind Method; D005190:Family; D005260:Female; D005492:Folic Acid / Q000494:pharmacology / Q000627:therapeutic use*; D006710:Homocysteine / Q000097:blood*; D006801:Humans; D020138:Hyperhomocysteinemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007194:India; D008297:Male; D014805:Vitamin B 12 / Q000494:pharmacology / Q000627:therapeutic use*; D014806:Vitamin B 12 Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014803:Vitamin B Complex / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D006710:Homocysteine; D014803:Vitamin B Complex; D005492:Folic Acid; D014805:Vitamin B 12