Reducing Anemia Through Food Fortification at Scale

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

Interventions

OTHER

Fortified rice kernels

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.

Sponsors & Collaborators

• Government of Tamil Nadu, India

  collaborator OTHER

• Global Innovation Fund

  collaborator OTHER

• National AIDS Research Institute

  collaborator UNKNOWN

• King Philanthropies

  collaborator UNKNOWN

• Stanford University

  lead OTHER

Principal Investigators

• Norman G Miller, PhD · Stanford University

• Aprajit Mahajan, PhD · University of California, Berkeley

• Alessandro Tarozzi, PhD · Universitat Pompeu Fabra

• Reynaldo Martorell, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-04-01

Primary Completion

2020-10-31

Completion

2021-09-30

Countries

• India

Study Locations