Effectiveness of wheat soya blend supplementation during pregnancy and lactation on pregnancy outcomes and nutritional status of their infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan: a cluster randomized-controlled trial.

PURPOSE: We aimed to assess the effectiveness of wheat soya blend plus (WSBP) provided during pregnancy and lactation on weight gain during pregnancy, reduction of low birthweight (LBW), and improvement in nutritional status in infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan.

METHODS: A cluster randomized-controlled trial was conducted in Thatta and Sujawal districts in Pakistan from August 2014 to December 2016. A total of 2030 pregnant women were enrolled in the study. These women and their infants were followed during pregnancy and first 6 months of life. Pregnant women received a monthly ration of 5 kg (i.e., 165 g/day) of WSB + during pregnancy and the first 6 months of their lactation period.

RESULTS: There was no difference in weight gain during pregnancy between the intervention and control groups (n = 496, 326.7 g/week 95% CI 315.2-338.1 vs. (n = 507, 306.9 g/week, 95% CI 279.9-333.9 P = 0.192), after adjustment with different factors. The reduction in the prevalence of LBW was not different between intervention and control groups (n = 325, 34.0%, 95% CI 31.7-36.4, vs. (n = 127, 34.3%, 95% CI 27.2-41.5, P = 0.932). Significant reductions in risk of stunting (n = 1319 RR 0.85, 95% CI 0.73-0.99, P = 0.041), wasting (n = 1330 RR 0.77, 95% CI 0.65-0.91, P = 0.003), and underweight (n = 1295 RR 0.77, 95% CI 0.69-0.87, P < 0.001) were observed in infants at 6 months of age in the intervention as compared to the control group. However, no difference was noted on reduction in the risk of stunting among infants at 6 months of age in the intervention and control group (n = 1318 RR 0.91, 95% CI 0.78-1.07, P = 0.253) after adjustment. A significant reduction in anemia was noted (n = 1328 RR 0.94, 95% CI 0.91-0.98, P = 0.002) in infants at 6 months of age in the intervention as compared to the control group in adjusted analysis.

CONCLUSIONS: Provision of WSB + during pregnancy and the first 6 months of lactation is effective in reducing the risk of under nutrition and anemia in infants at 6 months of age. This study can potentially guide the government and donor agencies in investing in nutritional programmes, especially for pregnant and lactating women living in vulnerable settings.