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

This study has been completed.
Sponsor:
Collaborators:
McGill University
Cornell University
The Mathile Institute for the Advancement of Human Nutrition
Information provided by:
MicroNutrient Initiative
ClinicalTrials.gov Identifier:
NCT01032005
First received: December 11, 2009
Last updated: April 29, 2011
Last verified: April 2011
  Purpose

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).


Condition Intervention
Anemia
Iron Deficiency
Other: double fortified salt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Fortified Salt Intervention and Work Performance (Productivity) of Women Plantation Workers in West Bengal, India

Resource links provided by NLM:


Further study details as provided by MicroNutrient Initiative:

Primary Outcome Measures:
  • Work productivity (daily weight of tae picked) [ Time Frame: endline (after 10 mo consumption of DFS) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anemia and iron status [ Time Frame: Endline (after 10 mo consumption of DFS) ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: Endline after 10 mo consumption of DFS ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01032005

Locations
India
Micronutrient Initiative
Panighatta Tea Estate, West Bengal, India
Sponsors and Collaborators
MicroNutrient Initiative
McGill University
Cornell University
The Mathile Institute for the Advancement of Human Nutrition
Investigators
Principal Investigator: Grace Marquis, PhD McGill University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Grace Marquis, McGill University
ClinicalTrials.gov Identifier: NCT01032005     History of Changes
Other Study ID Numbers: DFS efficacy trial
Study First Received: December 11, 2009
Last Updated: April 29, 2011
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 16, 2014