Ramakrishnan 2012

Trial name or title	Impact of pre‐pregnancy micronutrient supplementation on maternal and child outcomes. Protocol identifier: NCT01665378. Setting: Vietnam.
Methods	Parallel, double‐blind randomised trial.
Participants	Inclusion criteria: 18‐35 years old. Currently married. Intends to live in the study area for the next 24 months. Plans to have children in the next year. Agrees to participate with informed consent. Exclusion criteria: Currently pregnant. Delivered in the previous 6 months. Regularly consumed IFA or MM supplements in the past 2 months. Severe anaemia (Hb < 7 g/L). History of high‐risk pregnancy including abruptio placenta, placenta previa, gestational diabetes, pregnancy‐induced hypertension, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use. Chronic haematological diseases, hereditary defects of red cells or Hb.
Interventions	Arms 1 and 2: experimental: multiple micronutrients. Multiple micronutrient groups receive: vitamin A (μg) 800 vitamin D (IU) 600 vitamin E (mg) 10 vitamin C (mg) 70 thiamine (mg) 1.4 riboflavin (mg) 1.4 niacin (mg) 18 vitamin B6 (mg) 1.9 vitamin B12 (μg) 2.6 folic acid (μg)* 2800 Iron (mg)* 60 zinc (mg) 15 copper (mg) 2 selenium (μg) 65 iodine (μg) 150. Arm 3 and 4: active comparator: iron and folic acid. Iron and folic acid groups receive: iron (60 mg) and folic acid (2800 μg), based on current WHO recommendations for WRA. Arm 5 and 6: placebo comparator: folic acid. Folic acid groups receive: 2800 μg FA once a week during the pre‐pregnancy period.
Outcomes	Primary outcomes: 1. Birth Size [Time Frame: At birth] [Designated as safety issue: No] Infants' weight, length and head circumference will be measured as early as possible within 24 hours after birth using standard procedures. All measurements will be obtained in duplicate by the same data collector. Weight‐for‐age and length‐for‐age z scores will be calculated using the 2006 WHO reference data. 2. Gestational Age [Time Frame: At birth] [Designated as safety issue: No] Gestational age will be calculated based on the date of last menstrual period. This method has been shown to be reliable in previous work and we expect precise estimates since we will be visiting women weekly from baseline during the pre‐pregnancy period and will exclude women who may be have delivered in the past 6 months. Secondary outcomes: Maternal and infant iron status.
Starting date	October 2011 ‐ September 2014.
Contact information	Dr. Usha Ramakrishnan, Emory University.
Notes	Sponsor: Emory University. Collaborator: MicroNutrient Initiative.