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

NCT ID: NCT05166980

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2024-05-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

FePP-Q5S

Salt fortified with iron in the form of ferric pyrophosphate (at 1.3 mg of iron per gram of salt) plus ethylenediaminetetraacetic acid (EDTA) as an enhancer of absorption, zinc in the form of zinc oxide (at 1.4 mg of zinc per gram of salt), vitamin B12 (at 0.6 ug of vitamin B12 per gram of salt), folic acid (at 52 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the FePP-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day.

Group Type: EXPERIMENTAL

Mutiply-fortified salt

Intervention Type: DIETARY_SUPPLEMENT

Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine

eFF-Q5S

Salt fortified with iron in the form of encapsulated ferrous fumarate (at 1.3 mg of iron per gram of salt), zinc in the form of zinc oxide (at 1.4 mg of zinc per gram of salt), vitamin B12 (at 0.6 ug of vitamin B12 per gram of salt), folic acid (at 52 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the eFF-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day.

Group Type: EXPERIMENTAL

Mutiply-fortified salt

Intervention Type: DIETARY_SUPPLEMENT

Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine

Iodized Salt

Iodized salt containing 30 mg of iodine per gram of salt. Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the iodized salt will deliver an average of 138 mg of iodine to each participating woman per day.

Group Type: ACTIVE_COMPARATOR

Iodized salt

Intervention Type: DIETARY_SUPPLEMENT

Salt fortified with iodine

Interventions

Mutiply-fortified salt

Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine

Intervention Type: DIETARY_SUPPLEMENT

Iodized salt

Salt fortified with iodine

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Quintuply-fortified salt; Salt fortified with iodine

Eligibility Criteria

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);

4. Child's family is a 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;

5. No serious medical problems that interfere with the child's eating practices;

6. Child's mother or primary female caregiver is willing to use refined salt provided by the study as the primary source of the household's discretionary salt for the course of the study.

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);

4. Child's family is not a permanent resident of the study village and/or has plans to travel outside the village for more than 4 weeks over the next 12 months;

5. Serious health problem that interferes with the child's eating practices;

6. Child's mother or primary female caregiver is unwilling to use refined salt provided by the study as the primary sources of the household's discretionary salt for the course of the study.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine McDonald, ScD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh, , India

Countries

India

References

Goh YE, Duggal M, Das R, Manger MS, Jamwal M, Singh BL, Brar GK, Long JM, Westcott J, Thompson L, Arnold CD, Krebs NF, Brown KH, McDonald CM. Effects of quintuply-fortified salt on the micronutrient status of females of reproductive age in Punjab, India: a randomized, community-based trial. Am J Clin Nutr. 2025 Jul;122(1):146-156. doi: 10.1016/j.ajcnut.2025.04.009. Epub 2025 Jun 6.

Reference Type: DERIVED

PMID: 40610127 (View on PubMed)

McDonald CM, Brown KH, Goh YE, Manger MS, Arnold CD, Krebs NF, Westcott J, Long JM, Gibson RS, Jamwal M, Singh BL, Dahiya N, Budhija D, Das R, Duggal M. 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. BMC Nutr. 2022 Sep 6;8(1):98. doi: 10.1186/s40795-022-00583-y.

Reference Type: DERIVED

PMID: 36068647 (View on PubMed)

Other Identifiers

MFS_1.2

Identifier Type: -

Identifier Source: org_study_id