Free DFS - Intervention to fight anemia and improve well-being in a very low income setting

Last registered on May 15, 2013

Pre-Trial

Trial Information

General Information

Title
Free DFS - Intervention to fight anemia and improve well-being in a very low income setting
RCT ID
AEARCTR-0000010
First published
May 15, 2013, 10:14 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
CESS Nuffield - FLAME University

Other Primary Investigator(s)

PI Affiliation
MIT
PI Affiliation
MIT

Additional Trial Information

Status
On going
Start date
2011-04-04
End date
2014-06-01
Secondary IDs
Abstract
Iron deficiency anemia (IDA) has been linked to low productivity in adults, slowing of cognitive and physical growth among children and, in the elderly, increased risk of cognitive impairment and physical disability, as well as decreased muscle strength. While iron deficiency anemia has been recognized to be a serious public health problem in developing countries for several years, something that both limits the working population and increases risks for cognitive impairment and health shocks in the elderly, not much progress has yet been made against it. Distributing iron supplements appears to be an impractical policy in resource-poor settings where the public health systems do not have the capacity to maintain a large-scale distribution system. Iron supplementation of foods is therefore an attractive alternative: it requires no additional effort on the part of the consumer, and can be done relatively cheaply in centralized locations.

This study measures the impact of giving free Double (Iron and Iodine) Fortified Salt to randomly assigned households in 62 villages, compared to households who were randomly assigned to no free salt. The households which we give DFS will still choose whether to use free DFS or not, which will constrain potential health benefits. We expect to observe increases in haemoglobin, particularly among individuals anemic at baseline if households respond to the offer of free salt by using it to cook human food.
External Link(s)

Registration Citation

Citation
, , Sharon Barnhardt and Esther Duflo. 2013. "Free DFS - Intervention to fight anemia and improve well-being in a very low income setting." AEA RCT Registry. May 15. https://doi.org/10.1257/rct.10
Former Citation
, , Sharon Barnhardt and Esther Duflo. 2013. "Free DFS - Intervention to fight anemia and improve well-being in a very low income setting." AEA RCT Registry. May 15. https://www.socialscienceregistry.org/trials/10/history/14
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
We deliver free Double Fortified Salt manufactured in India by Tata Chemicals Ltd. to homes of subjects at the rate of 0.8 kg per month per treated household for approximately 7 - 11 months.
Intervention Start Date
2013-05-11
Intervention End Date
2014-06-01

Primary Outcomes

Primary Outcomes (end points)
Hemoglobin level, physical health, cognition (memory), school/work attendance and time use.
Primary Outcomes (explanation)
Hemoglobin level measured by hemocue, anemia, BMI, Mid-Upper Arm Circumference, Number of Activities of Daily Living that can be completed, Self-reported health, Queens College Step Test, Time to walk 4 meters, Time to sit and stand up 5 times in a row, Depression index based on the CES-D from self-reports on mental states.

The Lucknow Development Screen for infant development, Memory batteries for children (digit spans from PGI Memory Scales and block tapping test from the NIMHANS child neurpsoychology tests), Memory for adults (four subtests of the PGI Memory Scale), Hindi Mental State Exam for adults over 50.

School attendance, work attendance, value of consumption, and time use including hours of work.

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We randomly selected 62 villages participating in another trial where Double Fortified Salt is being made available for sale in stores and where a baseline survey had been completed with all members of 15 households per village. We randomly assigned 7 households per village to receive free DFS and the other 8 households to not receive free DFS.
Experimental Design Details
Randomization Method
Computer generated randomization done in office outside study district.
Randomization Unit
Households
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
930 households
Sample size: planned number of observations
6045 individuals
Sample size (or number of clusters) by treatment arms
2821 individuals free DFS, 3224 individuals no free DFS
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
IFMR (Chennai)
IRB Approval Date
2013-04-24
IRB Approval Number
IRB00007107; FWA00014616; IORG0005894
IRB Name
MIT
IRB Approval Date
2013-04-26
IRB Approval Number
1101004293

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials