Download StudyGeneral

Study Overview

Title:
Impact Evaluation of Integrating Double Fortified Salt (DFS) to Reduce Anemia in recipients of the PDS Program in UP, India
Study ID:
RIDIE-STUDY-ID-58f6eeb45c050
Initial Registration Date:
04/18/2017
Last Update Date:
06/27/2017
Study Status:
Ongoing
Abstract:
We propose an evaluation of a double fortified salt (DFS) program in Uttar Pradesh (UP) on reduction of anemia in women of reproductive age (WRA) who are recipients of the Public Distribution System (PDS). The UP government is funding the distribution and supporting the subsidized sale of DFS through the PDS in ten districts for a period of three years; the results of this evaluation will be used to make decisions related to continuity and further scale-up. We propose a longitudinal study of 2880 households which have access to the PDS, selected from five intervention districts five control districts using a 2-stage cluster randomized sampling strategy. The five intervention districts chosen for this evaluation were randomly selected from the ten which are intended to receive the DFS program starting in January 2017; control districts were randomly selected based on adjacency to the five intervention districts. The primary objective is to examine prevalence of anemia in WRA and coverage and utilization of the DFS through the PDS. Timing of the endline survey will be determined based on coverage surveys throughout the planned three-year program period.
Categories:
Health, Nutrition, and Population
Additional Keywords:
nutrition, double fortified salt, uttar pradesh, india, micronutrient malnutrition
Secondary ID Number(s):
2016-109-CP-exp Sanjay Gandhi Postgraduate Institute of Medical Sciences

Principal Investigator(s)

Name of First PI:
Dr. Lynnette Neufeld
Affiliation:
Global Alliance for Improved Nutrition
Name of Second PI:
Dr. Sumathi Swaminathan
Affiliation:
St John's Research Institute
Intervention

Intervention Overview

Intervention:
The program plans to distribute Double Fortified Salt (DFS) at a subsidized rate through the Public Distribution System (PDS) in 10 districts in Uttar Pradesh (UP). Expected beneficiaries are recipients of the Public Distribution System in those districts. There are three types of ration cards and entitlements/prices differ based on which is owned by the head of the household: Above-the-poverty-line (APL), 2) Below-the-poverty-line (BPL) and 3) Antyodaya Anna Yojana (AAY) which targets the poorest families. The main project objective is to develop a cost-effective and sustainable means to reducing the incidence of anemia by 1) refining, transferring and scaling up technology for DFS, 2) facilitating its large scale application through the PDS in UP, 3) developing a base of evidence to inform public policy with aim of mass implementation through eventual government decree in India and elsewhere.
Multiple Treatment Arms Evaluated?
No

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
05/01/2017
Change History for Start Date
Changed On Previous Value
06/27/2017 01/01/2017
End Date:
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Matching
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
We propose a longitudinal study to examine prevalence of anemia in 2880 non-pregnant women of reproductive age (WRA) living in intervention and control communities. Out of the ten districts chosen to be included in the DFS program by the UP government, five were randomly selected to be included in this evaluation; five adjacent districts were randomly selected to serve as controls. Control districts were chosen based on adjacency to the intervention districts to ensure that individuals match on socio-economic and –demographic factors which may also influence prevalence of anemia. We expect little spillover to occur given the PDS ration shops strictly serve communities within their jurisdiction and these communities are separated by the district borders. We propose to use linear mixed models adjusted for clustering to examine the difference-in-difference in prevalence of anemia in WRA who are recipients of the PDS.
Outcomes (Endpoints):
Change in prevalence of anemia in non-pregnant women of reproductive age. Utilization, consumption, and acceptability of Double Fortified Salt among recipients of the Public Distribution System.
Unit of Analysis:
Non-pregnant women of reproductive age
Hypotheses:
We hypothesize a at least a 20 percentage point drop in the prevalence of anemia in non-pregnant women of reproductive age who are recipients of the Public Distribution System. A study by Anderson et al (2008) demonstrated a 60% reduction in anemia in school-aged children using 2mg Fe/g of salt. The current study will use a formulation for the DFS that includes a maximum of 1050ppm of iron (as ferrous fumarate), which would result in a mean daily intake of 11.5mg (95% CI 9.8, 13.2) of iron per day. Given this is an effectiveness trial and given the lower concentration of iron in the present study compared to Anderson et al's 2008 trial, we use a conservative estimate and hypothesize a 20 percentage point reduction in anemia (from 75% to 55%). Current prevalence of anemia is based on the CAB 2014.
Unit of Intervention or Assignment:
District
Number of Clusters in Sample:
10
Number of Individuals in Sample:
2880 individuals
Size of Treatment, Control, or Comparison Subsamples:
Five intervention and five control districts will be matched at the district level, to ensure they match on socio-economic and –demographic characteristics which may influence anemia (other than DFS).
Data

Outcomes Data

Description:
At baseline, a household survey will examine socio-demographic and –economic factors, access to and perceptions of ration shops, etc. A 24 hour recall questionnaire will be used to assess dietary intake. We plan to take anthropometry and blood measurements. Blood samples will be analyzed for anemia, iron, vitamin A, vitamin D, folic acid, vitamin B12, zinc, iodine, malaria, inflammation, and beta-thalassemia status. As of now, at endline, a household survey and hemoglobin will be measured.
Data Already Collected?
No
Survey Name:
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: