A Randomized Multiple Micronutrient Powder Point-of-Use Fortification Trial Implemented in Indian Preschools Increases Expressive Language and Reduces Anemia and Iron Deficiency.

BACKGROUND: Anemia is a global public health problem that undermines childhood development. India provides government-sponsored integrated nutrition/child development preschools. OBJECTIVES: This double-masked, cluster-randomized controlled trial examines whether point-of-use multiple micronutrient powder (MNP) compared with placebo fortification of preschool meals impacts child development and whether effects vary by preschool quality (primary outcome) and biomarkers of anemia and micronutrients (secondary outcomes). We also measured growth and morbidity. METHODS: We randomly assigned 22 preschools in rural India to receive MNP/placebo fortification. We administered baseline and endline blood sampling and measures of childhood development (Mullen Scales of Early Learning, inhibitory control, social-emotional), anthropometry, and morbidity to preschoolers (aged 29-49 mo). Preschools added MNP/placebo to meals 6 d/wk for 8 mo. We conducted linear mixed-effects regression models accounting for preschool clustering and repeated measures. We evaluated child development, examining effects in high- compared with low-quality preschools using the Early Childhood Environment Rating Scale-Revised and the Home Observation for the Measurement of the Environment Inventory, modified for preschools. RESULTS: At baseline, mean age ± SD was 36.6 ± 5.7 mo, with 47.8% anemic, 41.9% stunted, and 20.0% wasted. Baseline expressive/receptive language scores were higher in high-quality compared with low-quality preschools (P = 0.02 and P = 0.03, respectively). At endline (91% retention, n = 293/321), we found MNP compared with placebo effects in expressive language (Cohen's standardized effect d = 0.4), inhibitory control (d = 0.2), and social-emotional (d = 0.3) in low-quality, not high-quality, preschools. MNP had significantly greater reduction of anemia and iron deficiency compared with placebo (37% compared with 13.5% and 41% compared with 1.2%, respectively). There were no effects on growth or morbidity. CONCLUSIONS: Providing multiple micronutrient-fortified meals in government-sponsored preschools is feasible; reduced anemia and iron deficiency; and, in low-quality preschools, increased preschoolers' expressive language and inhibitory control and reduced developmental disparities. Improving overall preschool quality by incorporating multiple components of nurturing care (responsive care, learning, and nutrition) may be necessary to enhance preschoolers' development. This trial was registered at clinicaltrials.gov as NCT01660958.

A food synergy approach in a national program to improve the micronutrient status of preschoolers: a randomized control trial protocol.

Iron deficiency anemia (IDA) is a significant public health issue in India affecting nearly all vulnerable segments of the population. Causes of IDA include low consumption of iron-rich foods combined with poor iron bioavailability of nonheme iron sources. To date, interventions aimed at correcting IDA focus on increasing iron intake through iron supplementation or fortification strategies. In contrast, dietary diversification is a long-term sustainable approach to improve bioavailable iron intake. In this context, the inclusion of vitamin C-rich fruits in the regular diet has proven to improve iron absorption, but the effect on iron status is inconclusive. Considering the ongoing national program for preschoolers in India, we designed a cluster randomized controlled trial (RCT) to test the hypothesis that inclusion of vitamin C-rich fruit in a regular meal would improve iron absorption and lead to better child iron and micronutrient status, cognitive development, gut health, and growth while reducing morbidity. This paper illustrates a context-specific framework and activities to design and functionalize an open-label, three-arm cluster RCT to test a specific hypothesis. The results of this designed trial should generate evidence to inform policy on the effect of a food-based intervention on iron status.

Association of Hip Bone Mineral Density and Body Composition in a Rural Indian Population: The Andhra Pradesh Children and Parents Study (APCAPS).

BACKGROUND: Fat mass is variably associated with bone mass, possibly due to differential mechanical and biological effects of fat mass. We examined the association of fat mass with bone mass in a lean population. OBJECTIVE: To investigate association between hip bone mineral density and fat and lean mass in a cross-sectional study from southern India. DESIGN: The Andhra Pradesh Children and Parents Study is a prospective cohort study in Hyderabad, India. In 2009-2012, the study collected data on anthropometric measures, bone mineral density (BMD), fat mass, and lean mass measured by dual-energy x-ray absorptiometry, and socioeconomic data of the adult participants (n = 1760; mean age = 34.9 years old for women; 2130 and 32.3 for men). RESULTS: The median BMI (kg/m2) was 20.1 kg/m2. Women had relatively higher fat mass as compared to men. In models adjusted for lean mass, there was an association between hip bone mineral density and fat mass in women (ß (95% confidence interval): premenopausal 0.025 (0.006 to 0.045); postmenopausal 0.045 (0.014 to 0.076)) but not in men (0.001 (-0.012 to 0.0014)). The association between hip BMD and fat mass was stronger in postmenopausal than premenopausal women. Hip BMD was consistently associated with lean mass, in both men and women. CONCLUSIONS: In this relatively lean population, lean mass was more consistently associated with hip BMD than fat mass. Weight gain through lean mass improvement may be a more reliable public health strategy for strengthening bone health in transitional settings.

Adolescent undernutrition and early adulthood bone mass in an urbanizing rural community in India.

The long-term effects on bone health of nutritional status in adolescence are unclear. The impact of adolescent and current body mass on bone mass in young adulthood in rural India was assessed. Current lean mass was a more important determinant of bone mass than thinness during adolescence in this population. PURPOSE/INTRODUCTION: Adolescence is a crucial period for skeletal growth. However, the long-term effects on bone health of nutritional status in adolescence, particularly in the context of nutritional transition, are unclear. The current manuscript assessed the impact of adolescent and current body size on bone mass in young adulthood in an Indian rural community that is undergoing rapid socioeconomic changes. METHODS: The Andhra Pradesh Children and Parents Study is a prospective cohort study in Hyderabad, India. In 2003-2005, the study collected anthropometric and cardiovascular data on adolescents (mean age = 16 years old). The second and third waves of the study in 2009-2012 collected data on current anthropometric measures, areal bone mineral density (aBMD) in hip and lumbar spine (L1-L4) measured by dual-energy X-ray absorptiometry, and living standards of the trial participants who were now young adults (mean age = 22 years old). RESULTS: The median body mass index (BMI) of the 722 participants included in this analysis was 16.8 kg/m(2) during adolescence, while the median BMI as young adults was 19.3 kg/m(2). Lower aBMD during adulthood was associated with lower adolescent BMI (ß (95 % confidence interval) for hip aBMD 0.017 (0.013 to 0.022) and LS aBMD 0.012 (0.008 to 0.016)). This association was attenuated upon adjustment for current fat and lean mass (ß (95 % CI) for hip aBMD 0.00 (-0.005 to 0.005) and LS aBMD 0.005 (0.000 to 0.01)). There was clear evidence for positive associations between aBMDs and current lean mass. CONCLUSIONS: Current lean mass was a more important determinant of bone mass than thinness during adolescence in this population. Weight gain during late adolescence and young adulthood coupled with improvement in lean mass may help to mitigate any adverse effects that pre-adulthood undernutrition may have on bone mass accrual.