Ramakrishnan 2012.

Trial name or title	Impact of pre‐pregnancy micronutrient supplementation on maternal and child outcomes.
Methods	6 arms double‐blind randomised controlled trial.
Participants	Eligible and willing women of reproductive age (WRA) from rural Vietnam.
Interventions	Aproximately 5000 women of reproductive age will be randomly assigned to 1 of the following 3 groups of pre‐pregnancy weekly supplementation: 1) folic acid 2800 μg (control), 2) iron and folic acid (iron 60 mg, folic acid 2800 μg), and 3) multiple micronutrients (vitamin A 800 μg, 600 IU vitamin D, 10 mg vitamin E, 70 mg vitamin C, 1.4 mg thiamine, 1.4 mg riboflavin, 18 mgNiacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 15 mg zinc, 2 mg copper, 65 μg selenium, 150 μg iodine + 2800 μg folic acid, 60 mg iron. Aproximately 1650 will become pregnant and will receive daily IFA during pregnancy. The mother‐infant pair will be follow to study anthropometrical and haematological parameters.
Outcomes	Key outcome measures will be 1) offspring's size and gestational age at birth 2) offspring's iron status at birth and 3 months of age and 3) maternal iron status at the beginning of pregnancy, 1 and 3 months postpartum.
Starting date	August 13, 2012.
Contact information	Usha Ramakrishnan
Notes	This project is a collaborative effort between Emory University, USA and Thainguyen University of Medicine and Pharmacy, Vietnam. Source of funding: Emory University, Micronutrient Initiative and The Mathile Institute for the Advancement of Human Nutrition This study is timely and responds to the WHO Global Expert Consultation (2007) which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. The findings will provide the necessary evidence to policy makers to recommend weekly MM or IFA supplements to WRA to improve birth outcomes. The central hypothesis is that pre‐pregnancy weekly IFA or MM supplementation followed by prenatal IFA and MM supplementation respectively, will improve birth outcomes as well as maternal and infant iron status compared to current practice of providing only prenatal IFA supplements. This hypothesis will be tested by conducting a randomised double‐blinded placebo‐controlled trial in Vietnam.