Abstract
BackgroundInadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.Methods/DesignA cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.DiscussionFindings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.Trial registrationNCT01084109
Highlights
Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings
Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children
Data Monitoring Committee As per the NIH Policy for Data Safety and Monitoring, the trial is overseen by a data monitoring committee (DMC)
Summary
Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Research Justification Among preventive measures that would reduce the excess mortality for children under the age of five years, exclusive breast feeding and good quality complementary feeding have been listed as first and third, respectively, with a calculated 600,000 deaths per year. Infants and young children bear the brunt of chronic malnutrition and suffer the greatest consequences, that is, the highest risks of morbidity and mortality [2,3,4]. This document re-emphasizes that lack of exclusive breastfeeding in the first half of infancy is a major risk factor for infant/ childhood morbidity and mortality, which is compounded by inappropriate complementary feeding. The complementary feeding (CF) trial is being conducted as a common protocol through the Global Network (GN) for Women’s and Children’s Health Research. A second criterion for inclusion was the general lack of exposure of the community to micronutrient-fortified products (e.g. cereal grain products, infant formulas) at the time of recruitment
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