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COMPLETEDNA

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

NCT05166980•University of California, San Francisco

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.

Eligibility

Age

1 - 49 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 18-49 years of age;
•2. Not currently pregnant (self-reported);
•3. Not severely anemia (defined as a hemoglobin concentration \< 8 g/dL);
•4. Not planning to become pregnant within the next year;
•5. Permanent resident of the study village with no plans to move or travel outside the village for more than 4 weeks over the next 12 months;
•6. No serious health problems that requires regular visits to a health facility;
•7. Willingness to use refined salt provided by the study as a primary source of household discretionary salt.
•1. Child 12-59 months of age at the time of enrollment;
•2. Child's mother or primary female caregiver has been enrolled into the parent trial;
•3. Not severely anemic (defined as a hemoglobin concentration \< 7 g/dL);
+3 more criteria

Exclusion Criteria

•1. Age \<18 or \> 49 years of age;
•2. Pregnant at the time of enrollment (self report) or planning to become pregnant within the next year;
•3. Severely anemic (i.e. hemoglobin concentration \< 8 g/dL);
•4. Not a permanent resident of the study area;
•5. Planning to leave the study area for at least one month over the study period;
•6. Serious health problem that interferes with eating practices and/or requires hospitalization;
•7. Unwilling to use refined salt provided by the study as the primary source of the household's discretionary salt.
•1. Child age \< 12 or \> 59 months of age;
•2. Child's mother has not been enrolled in the parent trial;
•3. Severely anemic (i.e. hemoglobin concentration \< 7 g/dL);
+3 more criteria

Locations (1)

Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh, India

Key Dates

Start Date

October 17, 2022

Primary Completion Date

May 2, 2024

Completion Date

May 2, 2024

Last Updated

May 3, 2024

Enrollment

1,389

ACTUAL participants

Conditions

Nutrient Deficiency

Interventions

Mutiply-fortified salt

DIETARY_SUPPLEMENT

Iodized salt

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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