Chicken liver and eggshell crackers are a safe and affordable animal source food for overcoming micronutrient deficits during pregnancy and lactation in Indonesia: a double-blind, cluster randomized controlled trial (SISTIK Growth Study).

backgroundPoor diets and micronutrient deficiencies during pregnancy and lactation are common in Indonesia, potentially affecting linear growth. National maternal programs focus predominantly on iron-folic acid (IFA) supplementation, but adherence is poor. We explored a strategy utilizing locally available micronutrient-rich foods in the form of micronutrient-enriched crackers (MEC) to improve neonatal and infant growth.

methodsThe Sustainable Intervention of Supplementation to Improve Kid's (SISTIK) Growth Study was a double-blind, cluster randomized controlled trial conducted in 28 village clusters in Sumedang, Indonesia (Nov 2020-Jan 2023). Villages-unit of randomization-were stratified by size and assigned to receive either MEC or standard wheat crackers (SWC), along with nutrition and health education, morbidity control, and national IFA supplementation programs. Eligible pregnant women (19-35 years; 7-13 weeks gestation) were enrolled participated. The intervention lasted through five months postpartum. Individual mother-infant dyads were the unit of analysis. Primary outcomes were birth length (cm), attained length (cm), LAZ-score, and length velocity (cm/month) from birth to five months postpartum. Secondary outcomes included birth weight, morbidity, and maternal hemoglobin (Hb) (g/dL). A general linear model, including village as a random effect and intervention as a fixed effect was used.

resultsIn each group 137 mother-infant dyads completed the study. Baseline characteristics were balanced. Intervention adherence was low (72-103 gr/week) compared to 525 gr/week (75 gr/day) recommended, with no significant intervention effect on growth outcomes, after adjusting for maternal height, sex, and human milk intake at 5 months. There were no differences between MEC and SWC groups in maternal Hb (mean ± SD) (12.0 ± 1.1 vs. 12.3 ± 1.2 g/dL) and anemia (11.9 vs 11.3%) at 35-36 weeks GA or morbidity. Compared with the same setting earlier at 5 mos pp, mean ± SD LAZ-score were less negative and stunting prevalence was lower in both groups. Overall, across the SISTIK study population, mean ± SD LAZ-score improved from -0.93 ± 0.85 to -0.51 ± 0.91, and stunting prevalence declined from 11 to 6%.

conclusionsAlthough this study did not show a treatment effect on the outcomes measured, future research should explore whether providing comprehensive nutrition and health support during pregnancy and post-partum could help reduce stunting in Indonesia.

trial registrationNCT04564222 (ClinicalTrials.gov); 25/09/2020.