Effect of fortified bovine colostrum on linear growth of children aged 9 to 36 mo: a community-based 3-arm randomized controlled trial in urban slums of Belagavi city, India.

BACKGROUND

Children living in urban slums are at heightened risk of stunting due to poor diet quality, frequent infections, and adverse living conditions. Fortified bovine colostrum (FBC) with zinc, rich in immunomodulatory and bioactive compounds, offers a promising strategy to improve growth outcomes.

OBJECTIVES

This study aimed to evaluate the effect of FBC on the linear growth of children aged 9 to 36 mo in urban slums of Belagavi city, India.

METHODS

A community-based, 3-arm randomized controlled trial (March 2023-August 2024) was conducted in the urban slums of Belagavi. Children (n = 362, mean age = 21 ± 8.7 mo) were randomly assigned to receive daily supplementation for 3 mo with either FBC (microencapsulated bovine colostrum + zinc), fortified milk powder (FMP; milk powder fortified with zinc and calcium, matched to FBC), or placebo (unfortified milk powder). Participants were followed at 3, 6, and 9 mo. The primary outcome was change in height/length-for-age z-scores (HAZ/LAZ). Linear regression models including time × group interactions and cluster-robust standard errors were used to estimate between-group differences.

RESULTS

After 9 mo, mean HAZ/LAZ improved in both intervention arms compared with placebo. The adjusted difference in HAZ/LAZ relative to placebo was 0.32 [95% confidence interval (CI): 0.08, 0.57] for FBC and 0.39 (95% CI: 0.14, 0.64) for FMP. Within-group HAZ/LAZ improvements were significant from 3 mo onward in both intervention arms, whereas the placebo group remained close to baseline. Direct comparisons between FBC and FMP showed no statistically significant differences in HAZ/LAZ at any follow-up time point.

CONCLUSIONS

Short-term supplementation with FBC or FMP improves linear growth compared with placebo among young children living in the urban slums of Belagavi. This trial was registered at Clinical Trials Registry-India as CTRI/2022/06/043002-03/06/2022.