Reducing Anemia Through Food Fortification at Scale

Anemia Clinical Trial

Official title: Reducing Anemia Through Food Fortification at Scale

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice using a domestically manufactured rice grain (Fortified Rice Kernels, or FRK). FRKs are grains made from rice flour, highly enriched with iron and other micronutrients (such as Vitamin A, B9 and Vitamin B12), and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratios (1g of FRK 100g of conventional rice) and is almost indistinguishable from conventional rice in appearance and taste. For this study, rice will be fortified using FRKs containing iron, zinc, vitamin A and vitamins B1, B3, B6, B9 and B12.

The Tamil Nadu PDS already provides up to 20 kilograms of rice at no cost to all households in the state, with an additional 15 kilograms to households identified as particularly poor. This is done through a widespread network of Fair Price Shops (FPS). The proposed study (implementation and accompanying evaluation) 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 will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS will continue receiving conventional rice. The investigators plan to conduct the study in one sub-district of Tamil Nadu with a population of about 1/2 million people.

In a cluster, the study team will randomly select 40 households to participate in the baseline and followup surveys and household members meeting the eligibility criteria, i.e. women between 12 and 40 years and children between 6 and 59 months, will be enrolled. These surveys will collect information about dietary patterns and socioeconomic status, and importantly, will also collect objectively measured health indicators (biomarkers and anthropometric measures), to test directly for anemia and micronutrient deficiencies.

To implement the intervention, the Government pre-existing PDS system, will be used. Every household in Tamil Nadu has a card that entitles it monthly to a pre-specified quantity of rice (and other goods) from a specific location that belongs to a network of so called Fair Price Shops (FPS). These FPS in turn receive rice from government-run warehouses (called godowns) where rice is delivered from a central procurement system and then bagged. ;

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT03573570
• Study type: Interventional
• Source: Stanford University
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2018
• Completion date: September 30, 2021