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NCT Number: NCT01032005

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Micronutrient Initiative

Panighatta Tea Estate, West Bengal, India

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

double fortified salt

Other

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.

Primary outcomes

  1. Work productivity (daily weight of tae picked)

    Time frame: endline (after 10 mo consumption of DFS)

Secondary outcomes

  1. Anemia and iron status

    Time frame: Endline (after 10 mo consumption of DFS)

  2. Cognitive function

    Time frame: Endline after 10 mo consumption of DFS

Sponsors and collaborators

Lead sponsor

Micronutrient Initiative

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DFS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2009
Registry last updated
May 2, 2011

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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