Supplementation with fortified balanced energy-protein during pregnancy and lactation and its effects on birth outcomes and infant growth in southern Nepal: protocol of a 2×2 factorial randomised trial

Authors

Daniel J. Erchick, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA derchick@jhu.edu.
Tsering P. Lama, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Subarna K. Khatry, Nepal Nutrition Intervention Project Sarlahi (NNIPS), Kathmandu, Nepal.
Joanne Katz, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Luke C. Mullany, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Eleonor Zavala, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Steven C. LeClerq, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Parul Christian, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
James M. Tielsch, Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.

Document Type

Journal Article

Publication Date

11-1-2023

Journal

BMJ paediatrics open

Volume

7

Issue

1

DOI

10.1136/bmjpo-2023-002229

Keywords

Epidemiology; Infant

Abstract

INTRODUCTION: Many women in low and middle-income countries enter pregnancy with low nutritional reserves with increased risk of fetal growth restriction and poor birth outcomes, including small-for-gestational-age (SGA) and preterm birth. Balanced energy-protein (BEP) supplements have shown reductions in risk of stillbirth and SGA, yet variations in intervention format and composition and limited evidence on the impact of BEP during lactation on growth outcomes warrant further study. This paper describes the protocol of the Maternal Infant Nutrition Trial (MINT) Study, which aims to evaluate the impact of a fortified BEP supplement during pregnancy and lactation on birth outcomes and infant growth in rural Nepal. METHODS AND ANALYSIS: MINT is a 2×2 factorial, household randomised, unblinded, efficacy trial conducted in a subarea of Sarlahi District, Nepal. The study area covers six rural municipalities with about 27 000 households and a population of approximately 100 000. Married women (15-30 years) who become pregnant are eligible for participation in the trial and are randomly assigned at enrolment to supplementation with fortified BEP or not and at birth to fortified BEP supplementation or not until 6 months post partum. The primary pregnancy outcome is incidence of SGA, using the INTERGROWTH-21st standard, among live born infants with birth weight measured within 72 hours of delivery. The primary infant growth outcome is mean length-for-age z-score at 6 months using the WHO international growth reference. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Board (IRB) at Johns Hopkins Bloomberg School of Public Health, Baltimore, USA (IRB00009714), the Committee on Human Research IRB at The George Washington University, Washington, DC, USA (081739), and the Ethical Review Board of the Nepal Health Research Council, Kathmandu, Nepal (174/2018). TRIAL REGISTRATION NUMBER: NCT03668977.

APA Citation

Erchick, Daniel J.; Lama, Tsering P.; Khatry, Subarna K.; Katz, Joanne; Mullany, Luke C.; Zavala, Eleonor; LeClerq, Steven C.; Christian, Parul; and Tielsch, James M., "Supplementation with fortified balanced energy-protein during pregnancy and lactation and its effects on birth outcomes and infant growth in southern Nepal: protocol of a 2×2 factorial randomised trial" (2023). GW Authored Works. Paper 3873.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/3873

Department

Global Health