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

May 2, 2024 updated by: University of California, San Francisco

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1389

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
      • Chandigarh, India
        • Postgraduate Institute of Medical Education and Research, Chandigarh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Dietary supplement: Mutiply-fortified salt
Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine
Other Names:
  • Quintuply-fortified salt
Experimental: 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.
Dietary supplement: Mutiply-fortified salt
Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine
Other Names:
  • Quintuply-fortified salt
Active Comparator: 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.
Dietary supplement: Iodized salt
Salt fortified with iodine
Other Names:
  • Salt fortified with iodine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in serum ferritin
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean serum ferritin concentration
Enrollment to 12 months (i.e. end of intervention period)
Change in hemoglobin
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean hemoglobin concentration
Enrollment to 12 months (i.e. end of intervention period)
Change in soluble transferrin
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean soluble transferrin concentration
Enrollment to 12 months (i.e. end of intervention period)
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
Enrollment to 12 months (i.e. end of intervention period)
Change in plasma zinc
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean plasma zinc concentration
Enrollment to 12 months (i.e. end of intervention period)
Change in serum vitamin B12
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum vitamin B12 concentration
Enrollment to 12 months (i.e. end of intervention period)
Change in holo-transcobalamin
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean holo-transcobalamin concentration
Enrollment to 12 months (i.e. end of intervention period)
Change in methylmalonic acid
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean concentration of methylmalonic acid
Enrollment to 12 months (i.e. end of intervention period)
Change in serum folate
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum folate concentration
Enrollment to 12 months (i.e. end of intervention period)
Change in urinary iodine
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean urinary iodine concentration
Enrollment to 12 months (i.e. end of intervention period)
Change in serum thyroglobulin
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum thyroglobulin concentration
Enrollment to 12 months (i.e. end of intervention period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in nail zinc
Time Frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean fingernail zinc concentration
Enrollment to 12 months (i.e. end of intervention period)
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
Enrollment to 12 months (i.e. end of intervention period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
University of California, Davis
Post Graduate Institute of Medical Education and Research, Chandigarh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine McDonald, ScD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MFS_1.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As soon as the manuscripts summarizing the study's primary outcomes are published, all datasets will be posted to Open Science Framework and made available to the public in accordance with the Gates Foundation's Open Data Policy.

IPD Sharing Time Frame

Data will become available as soon as the manuscripts summarizing the study's primary endpoints have been published. Data will be made available indefinitely.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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