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Completed

NCT Number: NCT05166980

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

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.

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Key information

Conditions

Age range

12 month–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for women of reproductive age:

  • 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

for women of reproductive age:

  • 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);
  • Not a permanent resident of the study area;
  • Planning to leave the study area for at least one month over the study period;
  • Serious health problem that interferes with eating practices and/or requires hospitalization;
  • Unwilling to use refined salt provided by the study as the primary source of the household's discretionary salt.

Inclusion criteria

for preschool children:

  • Child 12-59 months of age at the time of enrollment;
  • Child's mother or primary female caregiver has been enrolled into the parent trial;
  • Not severely anemic (defined as a hemoglobin concentration < 7 g/dL);
  • 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;
  • No serious medical problems that interfere with the child's eating practices;
  • 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:

  • Child age < 12 or > 59 months of age;
  • Child's mother has not been enrolled in the parent trial;
  • Severely anemic (i.e. hemoglobin concentration < 7 g/dL);
  • 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;
  • Serious health problem that interferes with the child's eating practices;
  • 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.

Treatment and study plan

Mutiply-fortified salt

Dietary Supplement

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

Other names: Quintuply-fortified salt

Iodized salt

Dietary Supplement

Salt fortified with iodine

Other names: Salt fortified with iodine

Primary outcomes

  1. Change in serum ferritin

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

    Change in inflammation-adjusted mean serum ferritin concentration

  2. Change in hemoglobin

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

    Change in mean hemoglobin concentration

  3. Change in soluble transferrin

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

    Change in inflammation-adjusted mean soluble transferrin concentration

  4. Change in red blood cell folate

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

    Change in mean red blood cell folate concentration

  5. Change in plasma zinc

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

    Change in mean plasma zinc concentration

  6. Change in serum vitamin B12

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

    Change in mean serum vitamin B12 concentration

  7. Change in holo-transcobalamin

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

    Change in mean holo-transcobalamin concentration

  8. Change in methylmalonic acid

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

    Change in mean concentration of methylmalonic acid

  9. Change in serum folate

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

    Change in mean serum folate concentration

  10. Change in urinary iodine

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

    Change in mean urinary iodine concentration

  11. Change in serum thyroglobulin

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

    Change in mean serum thyroglobulin concentration

Secondary outcomes

  1. Change in nail zinc

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

    Change in mean fingernail zinc concentration

  2. Change in gut microbiota

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

    Change in the abundance of potentially beneficial microbiota in the gut

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh
  • University of California, Davis
  • University of Colorado, Denver

Registry information

Acronym: MFS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2021
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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