Mridha 2014

Trial name or title	Rang‐Din Nutrition Study. Mridha 2014 (abstract) title: Lipid‐based nutrient supplements for pregnant women reduce newborn stunting in Bangladesh. Protocol identifier: NCT01715038. Harding 2014 documents trial methods and compliance.
Methods	Cluster‐randomised effectiveness trial
Participants	4011 pregnant women recruited. Inclusion criteria Gestational age ≤ 20 weeks. Planning to remain in the study area during pregnancy and the following 3 years (i.e. a permanent resident of the study area). Exclusion criteria Pregnancy identified and registered in the CHDP program before the beginning of the enrolment.
Interventions	1. Experimental: Comprehensive "Comprehensive" LNS: LNS‐PLW provided daily to mothers during pregnancy and postpartum lactation (a total of at least 11 months, starting by 20 weeks' gestation and ending at 6 months postpartum) and LNS developed for infants and young children (LNS‐child) provided daily to their infants (beginning at 6 months of age for a period of 18 months i.e. from 6‐24 months of age). 2. Experimental: child‐only LNS "Child‐only" LNS: daily LNS‐child supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. 3. Experimental: child‐only MNP "Child‐only" MNP: daily MNP supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum. 4. Active comparator: control: IFA. Control: no additional nutrient supplementation for the child will be provided through the study, but the regular nutrition education and visits provided by the program frontline staff will continue. Women will be provided with IFA tablets during pregnancy and for 3 months postpartum.
Outcomes	Primary outcome measures: 1. Birthweight [Time Frame: Within 48 hours (or back calculated from later measurements).] [Designated as safety issue: No]. Birthweight of the infants (women who received LNS‐PLW vs. women who received IFA tablets). Pre‐defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrolment), time of year when outcome was assessed and child sex. 2. Birth length [Time Frame: Within 48 hours (or back calculated from later measurements)] [Designated as safety issue: No]. Birth length of the infants (women who received LNS‐PLW vs. women who received IFA tablets). Pre‐defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrolment), time of year when outcome was assessed and sex of child. 3. Child linear growth status at 24 months [Time Frame: 24 months] [Designated as safety issue: No]. Linear growth (the "comprehensive" LNS approach vs. the "child‐only" LNS approach vs. "child‐only" MNP) vis‐à‐vis one another and vis‐à‐vis the control group. Pre‐defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrolment), time of year when outcome was assessed and sex of child. Secondary outcome measures: There are many additional maternal and neonatal outcomes listed on the protocol.
Starting date	October 2011 ‐ April 2015.
Contact information	Kathryn Dewey, University of California, Davis.
Notes	Study sponsors: University of California, Davis US Agency for International Development Family Health International 360 International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) World Mission Prayer League (LAMB) FANTA