Anemia Clinical Trial
Official title:
Reducing Anemia Through Food Fortification at Scale
Verified date | March 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Anemia is the most common form of malnutrition, affecting approximately 1.6 billion people world-wide. Most commonly caused by iron deficiency, its adverse effects include increased mortality (especially during childbirth), impaired cognitive development among children, chronic fatigue, and reduced lifetime earnings. While iron deficiency is the main cause of anemia worldwide, its etiology is complex and it can also be caused by an insufficient intake of other micronutrients such as Vitamin A, B9, B12 and folate as well as by helminthic infections and malaria. Research in India and elsewhere has shown that under ideal (controlled) conditions, anemia can be reduced by consumption of iron-fortified food and other micro-nutrients. However, much less is known about the effectiveness of such interventions under actual program conditions on a large scale. This trial proposes to address anemia and other micronutrient deficiencies by providing micronutrient fortified rice through the Public Distribution System (PDS) of Tamil Nadu in a manner that requires no change in behaviour by end-user households and that can feasibly be conducted on a large scale. This trial is designed as a rigorous cluster-randomized controlled trial with the full collaboration of the government of Tamil Nadu. The trial will follow a randomized cluster design at the Fair Price Shops (FPS) which distribute rice in the Tamil Nadu PDS. Fair Price Shops will be assigned randomly either to the treatment or the control arm, and will either be provided fortified rice for distribution, or the standard, non-fortified rice.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 30, 2021 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 40 Years |
Eligibility | Inclusion Criteria: - Children in the age group of 6 months to 5 years - Women in the age group of 12 to 40 years Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
India | Institute for Financial Management and Research (IFMR) and Cuddalore district, Tamil Nadu | Chennai | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Global Innovation Fund, Government of Tamil Nadu, King Philanthropies, National AIDS Research Institute |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | This will be assessed at baseline and at endline after 12-15 months of intervention. | |
Primary | 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. | This will be assessed at baseline and at endline after 12-15 months of intervention. | |
Primary | 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. C-Reactive Protein (CRP) will also be measured. 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. | This will be assessed at baseline and at endline after 12-15 months of intervention. | |
Primary | Change in anemia measured by RDT (Hemocue machine) and DBS from baseline to endline | 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 |
This will be assessed at baseline and at endline after 12-15 months of intervention. | |
Secondary | 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. | This will be assessed at baseline and at endline after 12-15 months of intervention. | |
Secondary | 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. | This will be assessed at baseline and at endline after 12-15 months of intervention. | |
Secondary | 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. | This will be assessed at baseline and at endline after 12-15 months of intervention. | |
Secondary | 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. | This will be assessed at baseline and at endline after 12-15 months of intervention. |
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