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. 2015 Nov 1;2015(11):CD004905. doi: 10.1002/14651858.CD004905.pub4
Trial name or title A randomised controlled trial to compare the impact on birthweight of daily iron folic acid, twice weekly iron folic acid and twice weekly multiple‐micronutrient supplementation for pregnant women in Ha Nam province, Vietnam.
Methods Randomised controlled trial. Communes agreeing to participate in the study will be randomly assigned to 1 of the 3 treatment arms. The commune was chosen as the cluster unit of randomisation to reduce the likelihood of interactions between the intervention groups. All eligible women in each commune will be invited to participate in the study. The pharmaceutical manufacturer and the Chairman of the DSMC will retain the allocation code.
Participants Healthy pregnant women 16 weeks' gestation or less were included. Women with complicated pregnancies (e.g. twins, diabetes, other medical conditions), or Hb ≤ 8.0 will be excluded.
Interventions Study has 3 arms. Group 1 will receive elemental iron 60 mg and folic acid 1.5 mg taken orally twice weekly, group 2 will receive multiple micronutrients (modified 2xUNIMAPP) taken orally twice weekly, and group 3 will receive elemental iron 60 mg and folic acid 0.4 mg taken orally once daily. All supplements will be provided for the duration of pregnancy and 3 months postpartum.
Outcomes Birthweight, maternal Hb and ferritin, infant cognitive development, infant height, Hb.
Starting date September 2010.
Contact information Beverley‐Ann Biggs
Department of Medicine Royal Melbourne Hospital Parkville, Victoria, 3050
Australia.
Tel # 61383443256
Email: babiggs@unimelbi.edu.au
Notes