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 was carried out at the five centres in India, viz., Bangalore, Mumbai, Lucknow, New Delhi and Pune. METHODS: The preparation contained 4 mg of folic acid besides calcium, iron, zinc and vitamins A, B1, B2, B6, C, D and nicotinamide. The placebo contained 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 the vitamin group and 235 in the placebo group). The supplementation was given for at least one month prior to conception and up to three months after conception. All women were offered antenatal diagnosis with screening of maternal 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 recurrence of open NTD in the vitamin group was 2.92 per cent compared to 7.04 per cent in the placebo group, a reduction by about 60 per cent. The difference, however, was not statistically significant (P = 0.06). INTERPRETATION & CONCLUSIONS: The study seems to support the role of periconceptional folic acid supplementation in prevention of recurrence of NTDs in the Indian population. The reason for high recurrence rate observed in the placebo group requires further investigation.
RCT Entities:
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 was carried out at the five centres in India, viz., Bangalore, Mumbai, Lucknow, New Delhi and Pune. METHODS: The preparation contained 4 mg of folic acid besides calcium, iron, zinc and vitamins A, B1, B2, B6, C, D and nicotinamide. The placebo contained 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 the vitamin group and 235 in the placebo group). The supplementation was given for at least one month prior to conception and up to three months after conception. All women were offered antenatal diagnosis with screening of maternal 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 recurrence of open NTD in the vitamin group was 2.92 per cent compared to 7.04 per cent in the placebo group, a reduction by about 60 per cent. The difference, however, was not statistically significant (P = 0.06). INTERPRETATION & CONCLUSIONS: The study seems to support the role of periconceptional folic acid supplementation in prevention of recurrence of NTDs in the Indian population. The reason for high recurrence rate observed in the placebo group requires further investigation.
Authors: Ellen A Nohr; Jorn Olsen; Bodil H Bech; Lisa M Bodnar; Sjurdur F Olsen; Janet M Catov Journal: Int J Epidemiol Date: 2014-01-21 Impact factor: 7.196
Authors: Olukunmi O Balogun; Katharina da Silva Lopes; Erika Ota; Yo Takemoto; Alice Rumbold; Mizuki Takegata; Rintaro Mori Journal: Cochrane Database Syst Rev Date: 2016-05-06