Reducing Anemia Through Food Fortification at Scale

NCT03573570 | Withdrawn

• 1 other identifier: IRB-35227
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (4)

• Change in height from baseline to endline

  This will be assessed at baseline and at endline after 12-15 months of intervention.

• Change in weight from baseline to endline

  This will be assessed at baseline and at endline after 12-15 months of intervention.

• Change in productivity from baseline to endline

  This will be assessed at baseline and at endline after 12-15 months of intervention.

• Change in cognitive outcomes for children from baseline to endline

  This will be assessed at baseline and at endline after 12-15 months of intervention.

Study Arms (2)

Treatment

EXPERIMENTAL

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) it should be straightforward to ensure that fortified rice reaches the appropriate treatment FPS and only those FPS.

Other: Fortified rice kernels

Control

NO INTERVENTION

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.

Interventions

Fortified rice kernels OTHER

The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice through Fair Price Shops (FPS) using a domestically manufactured rice grain (Fortified Rice Kernels: FRK). FRKs are grains made from rice flour, enriched with iron, zinc, Vitamin A, Vitamins B1, B3, B6, B9 and B12, and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratio of 1:100. The proposed study will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS, and all households receiving rice from them, will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS, and the households receiving rice from them, will continue receiving conventional rice and represents the status quo. This study will be conducted in one sub-district of Tamil Nadu with a population of about 1/2 million people.

Treatment

Eligibility Criteria

• Age: 6 Months - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children in the age group of 6 months to 5 years
• Women in the age group of 12 to 40 years

You may not qualify if:

• None

Sponsors & Collaborators

• Stanford University: lead
• Government of Tamil Nadu, India: collaborator
• Global Innovation Fund: collaborator
• National AIDS Research Institute: collaborator
• King Philanthropies: collaborator

Study Sites (1)

Institute for Financial Management and Research (IFMR) and Cuddalore district, Tamil Nadu

Chennai, Tamil Nadu, 600006, India

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Norman G Miller, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Aprajit Mahajan, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

• Alessandro Tarozzi, PhD

  Universitat Pompeu Fabra

  PRINCIPAL INVESTIGATOR

• Reynaldo Martorell, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Model Details: 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 Fair Price Shops (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 Public Distribution System (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.

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 29, 2018
• Study Start: April 1, 2018
• Primary Completion: October 31, 2020
• Study Completion: September 30, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: At the time of publication of the main paper from the project (and in perpetuity afterwards)
• Access Criteria: All shared materials will be publicly available i.e. there are no other access criteria

Locations

IN (1)