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Fields Changed

Registration

Field Before After
Trial Status in_development on_going
Trial Start Date April 15, 2018 July 01, 2018
Trial End Date March 15, 2020 April 15, 2020
Last Published February 08, 2018 05:24 AM August 09, 2018 05:16 AM
Intervention Start Date June 15, 2018 October 15, 2018
Intervention End Date October 15, 2019 January 15, 2020
Primary Outcomes (End Points) i. Rapid Diagnostic Tests (RDT) will be used to measure Hemoglobin concentrations in 80 individuals tested in each FPS catchment area (total sample size 17600 women and children). Hemoglobin (Hb) will be tested with the HemoCue analyzer, a portable, accurate system for measuring Hb. Hb measures will be used to calculate prevalence of anemia among the target population of women and young children. The test requires less than 0.5 ml of blood and delivers results in approximately 15 minutes. Transferrin Receptor (TfR), Hb and and C-Reactive Protein (CRP) will also be measured separately in a subsample of individuals (10 children and 10 women per FPS) using Dried Blood Spots that will be transported to a lab for analysis. TfR is a good indicator of iron stores in the body, and this marker is expected to improve following food fortification. CRP is useful both to detect the presence of inflammation and to identify cases where measured TfR is likely to give a biased account of iron stores, given that TfR becomes elevated in the presence of acute and sometimes chronic infections; thus, TfR will be corrected for inflammation using CRP. ii. Anthropometric data for children, specifically for height and weight for children that are 6 months and older will be collected. iii. Cognitive outcomes for children using Development Milestones Checklist instrument, as well as school enrollment and attendance data for older children will be measured. iv. Employment status, hours worked, productivity, and earnings will be measured for working age adults. v. Household socio-economic outcomes will be measured, using well-established recall methods to measure consumption data at the household level, with a particular emphasis on consumption of rice both from the PDS and from other sources. vi. Data from twenty-four (24) hour recalls to measure consumption of fortified rice and estimation of contribution of fortified rice to iron requirements for women and children will be collected. 1. Change in hemoglobin level from baseline to endline using Rapid Diagnostic Tests (RDT) Rapid Diagnostic Tests (RDT), using Hemocue machine, will be used to measure Hemoglobin concentrations in 40 women and 40 children tested in each FPS catchment area (total sample size 17600 women and children). Hemoglobin (Hb) will be tested with the HemoCue analyzer, a portable, accurate system for measuring Hb. Hb measures will be used to calculate prevalence of anemia among the target population of women and young children. The test requires less than 0.5 ml of blood and delivers results in approximately 15 minutes. [Time Frame: This will be measured at (1) Baseline, (2) Endline] 2. Change in hemoglobin level from baseline to endline using DBS Hemoglobin (Hb) will also be measured separately in a sub-sample of individuals (10 children and 10 women per FPS) using Dried Blood Spots (DBS) that will be transported to a lab for analysis. It will take up to 15 minutes for each respondent. [Time Frame: This will be measured at (1) Baseline, (2) Endline] 3. Change in Transferrin Receptor (TfR) level from baseline to endline using DBS Transferrin Receptor (TfR) will also be measured separately in a sub-sample of individuals (10 children and 10 women per FPS) using Dried Blood Spots (DBS) that will be transported to a lab for analysis. TfR is a good indicator of iron stores in the body, and this marker is expected to improve following food fortification. We will also be measuring C-Reactive Protein (CRP). CRP is useful both to detect the presence of inflammation and to identify cases where measured TfR is likely to give a biased account of iron stores, given that TfR becomes elevated in the presence of acute and sometimes chronic infections; thus, TfR will be corrected for inflammation using CRP. It will take up to 15 minutes for each respondent. [Time Frame: This will be measured at (1) Baseline, (2) Endline] 4. Change in anemia measured by RDT (Hemocue machine) and DBS from baseline to endline [Time Frame: This will be measured at (1) Baseline, (2) Endline]
Primary Outcomes (Explanation) Anemia measured by RDT (Hemocue machine) and DBS: Hb measured from RDT, i.e. Hemocue machine, and DBS will further be categorized to estimate the prevalence of anemia among the study population using established Hb thresholds. Based on the WHO classification, the following thresholds will be considered: For children aged 6 to 59 months: • No anemia: Hb >= 11 g/dL • Mild anemia: 10 < Hb < 10.9 g/dL • Moderate anemia: 7 < Hb < 9.9 g/dL • Severe anemia: Hb < 7 g/dL For non-pregnant women aged 12 years and above: • No anemia: Hb >= 12 g/dL • Mild anemia: 11 < Hb < 11.9 g/dL • Moderate anemia: 8 < Hb < 10.9 g/dL • Severe anemia: Hb < 8 g/dL For pregnant women aged 12 years and above: • No anemia: Hb >= 11 g/dL • Mild anemia: 10 < Hb < 10.9 g/dL • Moderate anemia: 7 < Hb < 9.9 g/dL • Severe anemia: Hb < 7 g/dL
Experimental Design (Public) This project (implementation and accompanying evaluation) will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12 months apart in the same individuals. In the interim, 110 Treatment FPS will be assigned randomly to receive rice fortified with iron and other micronutrients, and another 110 Control FPS will be assigned randomly to conventional PDS rice. The control arm therefore represents the status quo and serves as a control group against which any improvements observed in the treatment group will be gauged. Power calculations for different choices of parameters have been drawn up, with possibilities including 160 control clusters and 60 treatment clusters (with 40 tests per cluster); 150 control clusters and 50 treatment clusters (with 20 tests per cluster); and 120 control clusters and 60 treatment clusters (with 40 tests per cluster). Statistical power remains in the range of 70-90% even when different parameters are varied in the experimental design. Final decisions will be made keeping in mind logistical and budgetary constraints. Experimental: Treatment 110 Fair Price Shops (FPS) in Chidambaram, Tamil Nadu, India will be assigned randomly to receive rice fortified. Rice will be fortified using Fortified Rice Kernels (FRKs) containing iron, zinc, vitamin A and vitamins B1, B3, B6, B9 and B12. All households receiving rice from the PDS will receive fortified rice instead of conventional PDS rice, and members of households sampled for baseline will have blood samples and demographic surveys taken at a baseline visit, and another visit at 12-15 months after the baseline visit. Because a given FPS only receives rice from a single upstream distributor (godown) we will be able to ensure that fortified rice reaches the appropriate treatment FPS and only those FPS. No Intervention: Control: The control arm, i.e. FPS not a part of the treatment shops, will continue to receive the regular rice supplied by the Public Distribution System (PDS), and members of households sampled for baseline will have blood samples and demographic surveys taken at a baseline visit, and another visit at 12-15 months after the baseline visit. It therefore represents the status quo and serves as a control group against which any improvements observed in the treatment group will be gauged.
Secondary Outcomes (End Points) 5. Change in height from baseline to endline Height will be measured for all study participants (children that are 6 months and older, and women between the ages of 12 and 40 years) at baseline and endline. This will take up to 10 minutes. [Time Frame: This will be measured at (1) Baseline, (2) Endline] 6. Change in weight from baseline to endline Weight will be measured for all study participants (children that are 6 months and older, and women between the ages of 12 and 40 years) at baseline and endline. This will take up to 10 minutes. [Time Frame: This will be measured at (1) Baseline, (2) Endline] 7. Change in productivity from baseline to endline Employment status, hours worked, productivity, and earnings will be measured for working age adults at baseline and endline. This will take approximately 10 minutes. [Time Frame: This will be measured at (1) Baseline, (2) Endline] 8. Change in cognitive outcomes for children from baseline to endline Cognitive outcomes for children using Development Milestones Checklist and Wechsler Preschool and Primary Scale of Intelligence instruments, as well as school enrollment and attendance data for older children will be measured. This will take approximately 30 minutes to administer.
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