ClinicalTrials.Veeva

Menu

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

M

Micronutrient Initiative

Status

Completed

Conditions

Anemia
Iron Deficiency

Treatments

Other: double fortified salt

Study type

Interventional

Funder types

Other

Identifiers

NCT01032005
DFS efficacy trial

Details and patient eligibility

About

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).

Enrollment

248 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

248 participants in 2 patient groups, including a placebo group

Fortified salt
Placebo Comparator group
Description:
Common table salt that has been fortified with iodine only
Treatment:
Other: double fortified salt
Double fortified salt
Experimental group
Description:
Common table salt that has been fortified with iron and well as the usual iodine
Treatment:
Other: double fortified salt

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems