E.W. "Al" Thrasher
Status: Funded - Open
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 will be nested within a randomized, controlled, community-based efficacy trial of FePP-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 will occur at the level of the woman/household. Children 12-59 months of age in Mohali district, in the state of Punjab, India whose mothers have been enrolled in the parent trial and who are not severely anemic (hemoglobin < 7 g/dL) will be eligible to participate in the trial. RESULTS: Pending. IMPACT: If proven efficacious, MFS has the potential to drastically reduce the burden of MN deficiencies not only in India, but globally as well. Although effectiveness research will be needed to examine the impact of MFS under “real world” conditions, salt fortification will “piggy-back” on existing platforms to produce IS and DFS, making it possible to scale-up the intervention quickly. Website Link: www.izincg.orgOptional/Additional Comments: The parent study is funded by the Bill & Melinda Gates Foundation.