Preconception maternal strongnutritionstrong a multi-site randomized.PDFVIP

Hambidge et al. BMC Pregnancy and Childbirth 2014, 14:111 /1471-2393/14/111 STUDY PROTOCOL Open Access Preconception maternal nutrition: a multi-site randomized controlled trial 1* 1 1 2 3 K Michael Hambidge , Nancy F Krebs , Jamie E Westcott , Ana Garces , Shivaprasad S Goudar , 3 4 5 6 7 8 Balachandra S Kodkany , Omrana Pasha , Antoinette Tshefu , Carl L Bose , Lester Figueroa , Robert L Goldenberg , Richard J Derman9 1 1 10 10 10 , Jacob E Friedman , Daniel N Frank , Elizabeth M McClure , Kristen Stolka , Abhik Das , Marion Koso-Thomas11, Shelly Sundberg12 and For the Preconception Trial Group Abstract Background: Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design: This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) sup