Efficacy of Double Fortified Salt (DFS) to Improve Work Productivity in Women in India (DFS)

April 29, 2011 updated by: Micronutrient Initiative

Double Fortified Salt Intervention and Work Performance (Productivity) of Women Plantation Workers in West Bengal, India

The main objective of the present study is to assess the impact of double fortified salt containing iron and iodine on work performance (productivity) of women plantation workers in India. Efficacy studies have shown that salt double-fortified with iodine and iron can significantly reduce the incidence rates of iron-deficiency anemia (IDA) and iodine-deficiency disorders. Double-fortified salt (DFS) can be prepared by mixing microencapsulated iron compounds into conventionally iodated salt (Yuan et al, 2008). Iron deficiency anemia affects the work productivity and physical activity. Many studies have shown that when the individuals with low Hb received iron supplement, their work performance improved markedly. Animal studies have demonstrated that iron deficient anemic rats had a lower work tolerance as measured by oxygen consumption than the adult rats with normal Hb levels (Ohira et al, 1981). Several human studies have demonstrated the effect of iron supplementation on endurance capacity and work productivity in women (Zhu and Haas, 1997, 1998; Edgerton et al., 1979). Many human studies have also examined the possible linkages between iron deficiency and concurrent cognitive or behavioral outcomes. Iron supplementation effective in reducing iron-deficiency anemia would also result in better behavioral and developmental outcome. Many studies found that IDA had a great influence on cognitive functions in infants and school children (Lozoff et al., 2003, 1998 and Friel et al., 2003). However, studies of IDA and cognitive function in adults are few and controversial.

This study will assess iron status and physical and mental performance at 2 time points, before and after approximately 10 months during which a controlled intervention will take place on tea estates at the Panighatta Tea Garden near Siliguri, West Bengal. Subjects will be women between 18 and 50 years of age who are actively employed as full time tea pickers. The study requires that 2 experimental groups of subjects be identified: a) an experimental group that consumes double fortified salt (DFS) containing iron + iodine, and b) a control group that consumes only iodized salt (IS).

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

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Study Type

Study Type

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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.
248

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 Locations

  • India
    • West Bengal
      • Panighatta Tea Estate, West Bengal, India
        • Micronutrient Initiative

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Experienced, permanent, full-time tea pickers who plan to work for at least 2 picking seasons

Exclusion Criteria:

  • Pregnant and lactating women
  • Women with physical or mental disabilities that inhibit their ability to understand the study procedures or conduct their usual work (tea picking)

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: Triple

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.
Placebo Comparator: Fortified salt
Common table salt that has been fortified with iodine only
Other: double fortified salt
Refined salt of particle size < 1 mm iodized with potassium iodate (KIO3) at a concentration of 30 µg I/g salt at the factory will be purchased and blended with encapsulated Ferrous Fumarate premix containing 15% iron. Premix to salt ratio of 1 to 150 will be used to arrive at 1000 ppm elemental iron in the final product.
Experimental: Double fortified salt
Common table salt that has been fortified with iron and well as the usual iodine
Other: double fortified salt
Refined salt of particle size < 1 mm iodized with potassium iodate (KIO3) at a concentration of 30 µg I/g salt at the factory will be purchased and blended with encapsulated Ferrous Fumarate premix containing 15% iron. Premix to salt ratio of 1 to 150 will be used to arrive at 1000 ppm elemental iron in the final product.

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
Time Frame
Work productivity (daily weight of tae picked)
Time Frame: endline (after 10 mo consumption of DFS)
endline (after 10 mo consumption of DFS)

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
Time Frame
Anemia and iron status
Time Frame: Endline (after 10 mo consumption of DFS)
Endline (after 10 mo consumption of DFS)
Cognitive function
Time Frame: Endline after 10 mo consumption of DFS
Endline after 10 mo consumption of DFS

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.
Micronutrient Initiative

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.
McGill University
Cornell University
The Mathile Institute for the Advancement of Human Nutrition

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: Grace Marquis, PhD, McGill University

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

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Study Major Dates

Study Start

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.
May 1, 2009

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.
September 1, 2010

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.
September 1, 2010

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 11, 2009

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 14, 2009

First Posted (Estimate)

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 15, 2009

Study Record Updates

Last Update Posted (Estimate)

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 2, 2011

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.
April 29, 2011

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.
April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • DFS efficacy trial

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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