Multicentric study of efficacy of periconceptional folic acid containing vitamin supplementation in prevention of open neural tube defects from India

Background & objectives : A folic acid containing multivitamin preparation was evaluated for its efficacy in preventing recurrence of open neural tube defect (NTD) in a blind, placebo-controlled randomized trial. The trial wa s carried out at the five centres in India, viz., Bangalore, Mumbai, Luckno w, New Delhi and Pune, Methods : The preparation contained 4 mg of folic acid besides calcium, iro n, zinc and vitamins A, B1, B2, B6, C, D and nicotinamide. The placebo cont ained calcium and iron only. A total of 466 women with previous history of giving birth to a child with open NTD were included in the trial (231 in th e vitamin group and 235 in the placebo group). The supplementation was give n for at least one month prior to conception and up to three months after c onception. All women were offered antenatal diagnosis with screening of mat ernal serum alpha foetoprotein (AFP) and ultrasound, Results : Pregnancy outcome with reference to recurrence of NTD was unknown in 137 women in the vitamin group and 142 in the placebo group. The recurr ence of open NTD in the vitamin group was 2.92 per cent compared to 7.04 pe r cent in the placebo group, a reduction by about 60 per cent. The differen ce, however, was not statistically significant (P=0.06). Interpretation & conclusions : The study seems to support the role of peric onceptional folic acid supplementation in prevention of recurrence of NTDs in the Indian population. The reason for high recurrence rate observed in t he placebo group requires further investigation.