E.W. "Al" Thrasher
Status: Funded - Open
Summary
BACKGROUND: Fortification of salt with multiple micronutrients (MNs) may be an effective way of improving the MN status of nutritionally vulnerable populations in India, as salt is centrally processed and universally consumed in fairly consistent amounts. New technology has enabled salt to be fortified with iron, folic acid, vitamin B12, and zinc, in addition to iodine; however, the efficacy of multiply-fortified salt (MFS) in improving concentrations of MN biomarkers in PSC is unknown. GAP: This study will determine the efficacy of quintuply fortified salt (FePP-Q5S; i.e. salt fortified with iron in the form of ferric pyrophosphate, zinc, folic acid, vitamin B12, and iodine) vs. iodized salt (IS) in improving the MN status of PSC in Mohali district, Punjab, India. HYPOTHESIS: • PSC in households that receive FePP-Q5S for 12 months will exhibit significantly higher concentrations of iron, zinc, folate, and vitamin B12 biomarkers vs. PSC in households that receive IS for 12 months. • There will be no significant differences in mean concentrations of iodine biomarkers among PSC in households that receive FePP-Q5S vs. IS for 12 months. METHODS: This study was nested within a randomized, controlled, community-based efficacy trial of eFePP-Q5S vs. eFF-Q5S (i.e. Q5S with iron as encapsulated ferrous fumarate) vs. IS for the improvement of MN status among WRA in the district of Mohali in Punjab, India. Randomization occurred at the level of the woman/household. 470 children 12-59 months of age in Mohali district, in the state of Punjab, India whose mothers were enrolled in the parent trial and who were not severely anemic (hemoglobin < 7 g/dL) were eligible to participate in the study. Micronutrient status was assessed at enrollment, 6 months and 12 months. Continuous outcomes were analyzed with linear regression and reported as means or geometric mean ratios, and binary outcomes were analyzed with logistic regression and reported as odds ratios. RESULTS: At baseline, the prevalence of anemia, iron deficiency anemia, hypozincemia, vitamin B12 insufficiency, and folate deficiency was 35%, 30%, 17%, and 3.6%, respectively. Effects of QFS at 6 and 12 months were greatest for vitamin B12 and folate. At 12 months, the eFePP-QFS group had higher serum vitamin B12 (GMR=1.16; 95% CI: 1.03, 1.30), serum folate (GMR = 1.29, 95% CI=1.09, 1.53), and RBC folate (GMR=1.21, 95% CI=1.05, 1.39) concentrations compared to the iodized salt group. Effects were similar among the EFF-QFS group vs. iodized salt group. There were no significant differences in serum zinc, ferritin, or urinary iodine between groups at 6 and 12 months. IMPACT: Multiply-fortified salt shows promise as a population-based intervention to improve vitamin B12 and folate status, and related child health and development outcomes. Effectiveness research is needed to examine impact under “real world” conditions. Website Link: www.izincg.orgOptional/Additional Comments: The parent study is funded by the Bill & Melinda Gates Foundation.
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