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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • 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

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
Intervention / Treatment
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

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

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

Micronutrient Initiative

Collaborators

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

Investigators

  • 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

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

May 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 14, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Estimate)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 29, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Anemia

Clinical Trials on double fortified salt

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe