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

Not Applicable

Completed

• Conditions: Anemia; Iron Deficiency
• Interventions: Other: double fortified salt

• Registration Number: NCT01032005
• Lead Sponsor: Micronutrient Initiative

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 248

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortified salt	double fortified salt	Common table salt that has been fortified with iodine only
Double fortified salt	double fortified salt	Common table salt that has been fortified with iron and well as the usual iodine

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Micronutrient Initiative; 🇮🇳 Panighatta Tea Estate, West Bengal, India