NCT05166980: MFS

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

Completed NA Last updated 3 May 2024

What this trial tests

NA trial testing Mutiply-fortified salt in Nutrient Deficiency in 1,389 participants. Completed in 2 May 2024.

Timeline

17 October 2022

Primary endpoint
2 May 2024

2 May 2024

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,389
Start date	17 October 2022
Primary completion	2 May 2024
Estimated completion	2 May 2024
Sites	1 location across India

Drugs / interventions tested

• Mutiply-fortified salt
• Iodized salt

Conditions studied

• Nutrient Deficiency — all drugs for Nutrient Deficiency →

Sponsor

University of California, San Francisco

Who can join

Adults 12 Months to 49, any sex, with Nutrient Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Quintuply-fortified salt for the improvement of micronutrient status among women of reproductive age and preschool-aged children in Punjab, India: protocol for a randomized, controlled, community-based trial.
   McDonald CM, Brown KH, Goh YE, Manger MS, et al · · 2022 · cited 11× · PMID 36068647 · DOI 10.1186/s40795-022-00583-y
2. Effects of quintuply-fortified salt on the micronutrient status of females of reproductive age in Punjab, India: a randomized, community-based trial.
   Goh YE, Duggal M, Das R, Manger MS, et al · · 2025 · cited 3× · PMID 40610127 · DOI 10.1016/j.ajcnut.2025.04.009
3. The Effect of Quintuply-Fortified Salt on the Gut Microbiome of Young Children 1-5 y of Age in Punjab, India; A Substudy of a Randomized, Community-Based Trial.
   Thompson L, Goh YE, Jamwal M, Singh BL, et al · · 2025 · PMID 41323692 · DOI 10.1016/j.cdnut.2025.107580