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

Anemia Clinical Trial

— DFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032005
• Other study ID #: DFS efficacy trial
• Status: Completed
• Phase: N/A
• First received: December 11, 2009
• Last updated: April 29, 2011
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: April 2011
• Source: Micronutrient Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

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.

Locations

Country	Name	City	State
India	Micronutrient Initiative	Panighatta Tea Estate	West Bengal

Sponsors (4)

Lead Sponsor	Collaborator
Micronutrient Initiative	Cornell University, McGill University, The Mathile Institute for the Advancement of Human Nutrition

Country where clinical trial is conducted

India, 

References & Publications (4)

Andersson M, Thankachan P, Muthayya S, Goud RB, Kurpad AV, Hurrell RF, Zimmermann MB. Dual fortification of salt with iodine and iron: a randomized, double-blind, controlled trial of micronized ferric pyrophosphate and encapsulated ferrous fumarate in southern India. Am J Clin Nutr. 2008 Nov;88(5):1378-87. — View Citation

Edgerton VR, Gardner GW, Ohira Y, Gunawardena KA, Senewiratne B. Iron-deficiency anaemia and its effect on worker productivity and activity patterns. Br Med J. 1979 Dec 15;2(6204):1546-9. — View Citation

Haas JD, Brownlie T 4th. Iron deficiency and reduced work capacity: a critical review of the research to determine a causal relationship. J Nutr. 2001 Feb;131(2S-2):676S-688S; discussion 688S-690S. Review. — View Citation

Vinodkumar M, Rajagopalan S, Bhagwat IP, Singh S, Parmar BS, Mishra OP, Upadhyay SS, Bhalia NB, Deshpande SR. A multicenter community study on the efficacy of double-fortified salt. Food Nutr Bull. 2007 Mar;28(1):100-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work productivity (daily weight of tae picked)		endline (after 10 mo consumption of DFS)	No
Secondary	Anemia and iron status		Endline (after 10 mo consumption of DFS)	No
Secondary	Cognitive function		Endline after 10 mo consumption of DFS	No