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Field Before After
Trial Start Date July 01, 2017 April 15, 2018
Trial End Date December 31, 2019 March 15, 2020
Last Published April 21, 2017 02:04 PM February 08, 2018 05:24 AM
Intervention Start Date August 15, 2017 June 15, 2018
Intervention End Date November 30, 2018 October 15, 2019
Primary Outcomes (End Points) i. Rapid Diagnostic Tests (RDT) will be used to measure Hemoglobin concentrations in80 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); and (3) C-Reactive Protein (CRP) will also be measured. 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 2 years and older will be collected. iii. Cognitive outcomes for children using Development Milestones Checklist instrument, as well as school enrolment 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. 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.
Planned Number of Observations In each area of the 220 FPS, 40 households will be randomly selected to participate in the baseline and endline surveys, i.e. a total of 8,800 women between ages of 15 and 45 years and 8,800 children between the ages of 6 to 59 months. These surveys will collect information about dietary patterns and socio-economic status and health indicators, enabling the direct testing of anemia and micronutrient deficiencies. In addition, a range of other outcomes looking both at cognitive measures as well as socio-economic outcomes such as employment and earnings will also be measured. In each area of the 220 FPS, we will obtain a list of all households from a census that will be conducted by our survey team. Households with at least one child 6-59 month old or a woman 12-40 will be ordered randomly using a random number generator in Stata, setting first a seed to ensure replicability. We will then conduct interviews following the randomized order until we have reached a total of 40 children and 40 women in each cluster. Interviews with the same households will be sought at endline. We thus expect to test a total of 220*40=8,800 women between ages of 12 and 40 years and 8,800 children between the ages of 6 to 59 months at baseline. Ideally we will select the same numbers at endline although given attrition the actual number of blood tests completed at endline will be lower.
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