CompletedNot Applicable

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

India1,389 participantsStarted 2022-10-17

Plain-language 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.

Who can participate

Age range12 Months – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-49 years of age;
✓. Not currently pregnant (self-reported);
✓. Not severely anemia (defined as a hemoglobin concentration \< 8 g/dL);
✓. Not planning to become pregnant within the next year;
✓. 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;
✓. No serious health problems that requires regular visits to a health facility;
✓. Willingness to use refined salt provided by the study as a primary source of household discretionary salt.

Exclusion criteria

✕. Age \<18 or \> 49 years of age;
✕. Pregnant at the time of enrollment (self report) or planning to become pregnant within the next year;
✕. Severely anemic (i.e. hemoglobin concentration \< 8 g/dL);

What they're measuring

Change in serum ferritin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in hemoglobin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in soluble transferrin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in red blood cell folate

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in plasma zinc

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in serum vitamin B12

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in holo-transcobalamin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in methylmalonic acid

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Trial details

NCT IDNCT05166980

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-02

View on ClinicalTrials.gov More Nutrient Deficiency trials

Plain-language summary

Who can participate

Age range12 Months – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-49 years of age;
✓. Not currently pregnant (self-reported);
✓. Not severely anemia (defined as a hemoglobin concentration \< 8 g/dL);
✓. Not planning to become pregnant within the next year;
✓. 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;
✓. No serious health problems that requires regular visits to a health facility;
✓. Willingness to use refined salt provided by the study as a primary source of household discretionary salt.

Exclusion criteria

✕. Age \<18 or \> 49 years of age;
✕. Pregnant at the time of enrollment (self report) or planning to become pregnant within the next year;
✕. Severely anemic (i.e. hemoglobin concentration \< 8 g/dL);

What they're measuring

Change in serum ferritin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in hemoglobin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in soluble transferrin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in red blood cell folate

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in plasma zinc

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in serum vitamin B12

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in holo-transcobalamin

Timeframe: Enrollment to 12 months (i.e. end of intervention period)

Change in methylmalonic acid

Timeframe: Enrollment to 12 months (i.e. end of intervention period)