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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032005
Acronym
DFS
Enrollment
248
Registered
2009-12-15
Start date
2009-05-31
Completion date
2010-09-30
Last updated
2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron Deficiency

Brief summary

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).

Interventions

OTHERdouble 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.

Sponsors

McGill University
CollaboratorOTHER
Cornell University
CollaboratorOTHER
The Mathile Institute for the Advancement of Human Nutrition
CollaboratorOTHER
Micronutrient Initiative
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Work productivity (daily weight of tae picked)endline (after 10 mo consumption of DFS)

Secondary

MeasureTime frame
Anemia and iron statusEndline (after 10 mo consumption of DFS)
Cognitive functionEndline after 10 mo consumption of DFS

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026