Effect of a multi-nutrient fortified supplement on immunity in Indian Children: A randomized controlled trial

An open label, two arm, matched pair, cluster randomized controlled trial was conducted to assess the impact of a multi-nutrient Fortified Malt-Based Food (FMBF) on immunity outcomes in Indian school going children (7-10 years). Participants (n=445) in test group schools received FMBF (27g in 150 mL lukewarm water) twice daily for 9 months along with dietary counselling (FMBF+DC); participants (n=462) in control group schools were provided DC alone. Study design and baseline data were published previously. This paper reports primary and secondary outcomes assessed at 3, 6, and 9 months. Primary outcomes included number of ill days due to gastrointestinal infections (GI) and acute respiratory infections (ARI). Secondary outcomes were frequency and severity of GI and ARI episodes, and school absenteeism related to these illnesses over the intervention period. The test group participants fell ill for 6 days (SE 0.234) lesser than the control group (p<0.001). Participants in the test group had less illness episodes/month (p<0.001), had overall less severity episodes for GI (p=0.0030) and ARI (p=0.0005) and were less absent from school at 9 months versus control group (p= 0.001). The improvements in immunity outcomes became evident from 3 months itself and continued at 6 and 9 months of intervention. Significant improvements in serum vitamin B12 (p=0.017), vitamin E (p<0.001), and selenium (p=0.016) were observed in the test group. In conclusion, nine months of FMBF supplementation alongside dietary counselling significantly improved immunity outcomes, reduced GI and ARI-related morbidity, decreased school absenteeism, and enhanced micronutrient status compared with dietary counselling alone.