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Intervention to fight anemia and improve well-being in a very low income setting
Last registered on May 16, 2013

Pre-Trial

Trial Information
General Information
Title
Intervention to fight anemia and improve well-being in a very low income setting
RCT ID
AEARCTR-0000013
Initial registration date
Not yet registered
Last updated
May 16, 2013 12:34 PM EDT
Location(s)
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
2014-09-01
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 is a cluster-randomized trial in Bhojpur District (Bihar) of Double (iron and iodine) Fortified Salt (DFS), a fortified food designed to prevent anemia. We randomly assign 200 villages where DFS is made available for purchase through private shops and PDS stores, and randomly assign 200 villages to no intervention. We also conduct an information campaign in each treatment village to tell households about the new product.

We measure health impact using all individuals in 15 randomly selected households within each village. They complete a baseline survey as well as an endline after approximately one year. The main outcomes of interest are haemoglobin level, anemia, weakness, absence from work/school and cognitive health.
External Link(s)
Registration Citation
Citation
Banerjee, Abhijit, Sharon Barnhardt and Esther Duflo. 2013. "Intervention to fight anemia and improve well-being in a very low income setting." AEA RCT Registry. May 16. https://doi.org/10.1257/rct.13-1.0.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
We make Double (iron and iodine) Fortified Salt (DFS) available for purchase, at a discount from the MRP, in 200 villages randomly assigned to this treatment. All 200 villages also receive an information/marketing campaign through posters and a street play conducted by actors.
Intervention Start Date
2012-08-27
Intervention End Date
2013-10-31
Primary Outcomes
Primary Outcomes (end points)
Hemoglobin & anemia, physical health, cognition, productivity.
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 are working in Bhojpur District of Bihar, and follow these procedures:
- Randomly select 400 villages to be part of the trial.
- Randomly assign 200 villages to be treated and 200 villages to serve as the control (where we do not intervene).
- Conduct baseline survey in 15 randomly selected households per village.
- Conduct information campaign and begin first round of salt stocking in stores. Stocking repeats for approximately one year.
- Every month, measure store sales, household take-up and hemoglobin in a small subset of villages for process monitoring.
- Conduct endline survey with same households.
Experimental Design Details
Randomization Method
Random assignment done by computer in office outside the study area.
Randomization Unit
Villages
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
400 villages
Sample size: planned number of observations
6000 households (about 39,000 individuals)
Sample size (or number of clusters) by treatment arms
3000 households in treatment and 3000 in control
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.7 g/dL among elderly subgroup
Supporting Documents and Materials

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IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
IFMR (Chennai)
IRB Approval Date
2011-05-02
IRB Approval Number
IRB00007107; FWA00014616; IORG0005894
IRB Name
MIT COUHES
IRB Approval Date
2011-11-08
IRB Approval Number
1101004293
IRB Name
Indian Council of Medical Research
IRB Approval Date
2012-01-10
IRB Approval Number
5/7/1008/Indo/FRC/2011-RHN
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers