Randomized Trial of Quadruple Fortified Salt (QFS)

Primary Investigator

  • Julia Finkelstein

Study Period

January 2021 - December 2022

Study Description

Brief Summary:

Neural tube closure defects (NTDs) are a common adverse pregnancy outcome and among the most severe birth defects in the United States and globally. Women of reproductive age are a high-risk population for anemia and micronutrient deficiencies, and there is increasing evidence of the role of periconceptional nutritional status in the risk of birth defects and other common pregnancy complications. However, there is little representative population-level data from Southern India, where the burden of micronutrient deficiencies and birth defects is estimated to be among the highest in the world. Salt fortification is a promising strategy to prevent anemia and multiple micronutrient deficiencies, as it utilizes a widely consumed and affordable food and existing production and distribution systems.

We propose to conduct the first randomized controlled efficacy trial of quadruple-fortified salt (QFS) - i.e., iron, iodine, folic acid, and vitamin B12. The primary objectives of this randomized controlled trial are to determine the efficacy of QFS on 1) folate status (erythrocyte and serum folate concentrations; folate deficiency and insufficiency), 2) hemoglobin concentrations and anemia, and 3) vitamin B12 status (vitamin B12 concentrations; vitamin B12 deficiency and insufficiency), among women of reproductive age (15-40 y) in Southern India. If proven to be efficacious, QFS could represent a low-cost and sustainable strategy to prevent anemia and micronutrient deficiencies and improve the the health of vulnerable populations, including women and young children.

Study Arms

  • Experimental: Quadruple-Fortified Salt (QFS) Salt fortified with iron, iodine, folic acid, and vitamin B12
  • Experimental: DFS + Folic acid Salt fortified with iron, iodine, and folic acid
  • Experimental: DFS + Vitamin B12 Salt fortified with iron, iodine, and vitamin B12
  • Active Comparator: Double-fortified salt (DFS) Salt fortified with iron and iodine

Primary Outcomes

  • Folate status [ Time Frame: Endline (12 months) ] Erythrocyte folate and serum folate concentrations, nmol/L
  • Hemoglobin [ Time Frame: Endline (12 months) ] Hemoglobin concentrations, g/dL
  • Vitamin B12 status [ Time Frame: Endline (12 months) ] Vitamin B12 concentrations, pmol/L

Study Intervention

  • Micronutrient powders (MNP)

Research Gaps

  • Composition

    Which ingredients offer the best prevention or treatment for undernutrition?

  • Effectiveness

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented "on the ground"?

Study Population

1000