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

Nutrient Deficiency Clinical Trial

— MFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166980
• Other study ID #: MFS_1.2
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: May 2, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1389
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 49 Years

Eligibility

Inclusion criteria for women of reproductive age:

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.

Exclusion criteria for women of reproductive age:

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.

Inclusion criteria for preschool children:

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 for preschool children:

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.

Related Conditions & MeSH terms

• Nutrient Deficiency

Intervention

Dietary Supplement:
• Mutiply-fortified salt
Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine
• Iodized salt
Salt fortified with iodine

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research, Chandigarh	Chandigarh

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Post Graduate Institute of Medical Education and Research, Chandigarh, University of California, Davis, University of Colorado, Denver

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum ferritin	Change in inflammation-adjusted mean serum ferritin concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in hemoglobin	Change in mean hemoglobin concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in soluble transferrin	Change in inflammation-adjusted mean soluble transferrin concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in red blood cell folate	Change in mean red blood cell folate concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in plasma zinc	Change in mean plasma zinc concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in serum vitamin B12	Change in mean serum vitamin B12 concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in holo-transcobalamin	Change in mean holo-transcobalamin concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in methylmalonic acid	Change in mean concentration of methylmalonic acid	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in serum folate	Change in mean serum folate concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in urinary iodine	Change in mean urinary iodine concentration	Enrollment to 12 months (i.e. end of intervention period)
Primary	Change in serum thyroglobulin	Change in mean serum thyroglobulin concentration	Enrollment to 12 months (i.e. end of intervention period)
Secondary	Change in nail zinc	Change in mean fingernail zinc concentration	Enrollment to 12 months (i.e. end of intervention period)
Secondary	Change in gut microbiota	Change in the abundance of potentially beneficial microbiota in the gut	Enrollment to 12 months (i.e. end of intervention period)