NCT05166980

Study of Multiply-fortified Salt Among Women of Reproductive Age and Preschool Children in India

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,389 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 12 Months – 49 Years
• Healthy volunteers: Accepted

Summary

Micronutrient (MN) deficiencies are highly prevalent in India, particularly among women of reproductive age (WRA) and preschool aged children (PSC). MN fortification of a staple food or condiment can be an effective strategy for improving the MN status of nutritionally vulnerable populations, as the approach is cost-effective, utilizes existing delivery systems, can deliver multiple MNs simultaneously, and does not require behavior change by the population. Salt is a particularly attractive vehicle for multiple MN fortification in India, as it is universally consumed in fairly consistent amounts; and 93% of households already use adequately iodized salt. The overall goal of this study is to evaluate the nutritional impact of quintuply-fortified salt with iron in the form of FePP (FePP-Q5S, i.e. salt fortified with iron in the form of ferric pyrophosphate plus ethylenediaminetetraacetic acid as an enhancer of absorption; zinc in the form of zinc oxide; vitamin B12; folic acid; and iodine) vs. quintuply-fortified salt with iron in the form of eFF (eFF-Q5S i.e. salt fortified with iron in the form of encapsulated ferrous fumarate; zinc in the form of zinc oxide, vitamin B12, folic acid, and iodine) vs. iodized salt (IS) for the improvement of micronutrient status among nonpregnant WRA and preschool-aged children (12-59 months of age) in Punjab, India. Enrolled women (and their affiliated households) will be randomized to receive 1 kg of their assigned study salt per month for 12 months, and will be instructed to use the study salt in place of their usual salt. Blood and urine samples will be collected from participant WRA and PSC at enrollment, 6 months and at the end of the 12-month intervention period. The change in the mean concentration of various MN biomarkers will be considered primary outcomes. Stool samples will also be collected from a subgroup of women and children to assess changes in the gut microbiome over the intervention period.

Conditions

• Nutrient Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mutiply-fortified salt	Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine
DIETARY_SUPPLEMENT	Iodized salt	Salt fortified with iodine

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2021-12-22
• Last updated: 2024-05-03

Locations

1 site across 1 country: India