Randomized Trial of Quadruple Fortified Salt for Anemia and Birth Defects Prevention in Southern India

Julia Finkelstein, ScD, MPH, Cornell University (Funded 2018)

The purpose of this project is to conduct the first randomized efficacy trial of quadruple fortified salt (QFS) (i.e., iron, vitamin B12, folate, iodine) for prevention of anemia and birth defects in Southern India. Due to the reduced availability of funds to support the proposed randomized efficacy trial, we revised the project budget to reduce funding for laboratory activities and personnel, and will focus efforts on the design and conduct of the randomized trial and collection and archival of samples for future laboratory analyses. We reduced the number of laboratory biomarkers to those that need to be conducted in real-time (i.e., hemoglobin) and scaled back the laboratory biomarkers to: hemoglobin erythrocyte and serum folate (WHO microbiological assay), and total serum vitamin B12 concentrations. However, the proposed study design, methods for data collection, and field activities for this randomized trial remain unchanged. Cornell University will provide expert guidance in the design and conduct of the randomized efficacy trial of QFS in Southern India and will work with CDC to leverage seed funding to support this trial, including additional laboratory analyses. Our subcontractor, Arogyavaram Medical Centre will conduct research field activities for the randomized efficacy trial of QFS at our research field site in South India, and will conduct proposed laboratory analyses (i.e., Hb, folate, vitamin B12), and archive samples for future analyses.