Clinical trial NCT03573570: Reducing Anemia Through Food Fortification at Scale
Official title: Reducing Anemia Through Food Fortification at Scale
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anemia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Government of Tamil Nadu, India
name: Global Innovation Fund
name: National AIDS Research Institute
name: King Philanthropies
First posted: 2018-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hemoglobin level from baseline to endline using Rapid Diagnostic Tests (RDT)
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
measure: Change in hemoglobin level from baseline to endline using DBS
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
measure: Change in Transferrin Receptor (TfR) level from baseline to endline using DBS
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
measure: Change in anemia measured by RDT (Hemocue machine) and DBS from baseline to endline
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Secondary outcomes:
measure: Change in height from baseline to endline
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
measure: Change in weight from baseline to endline
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
measure: Change in productivity from baseline to endline
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
measure: Change in cognitive outcomes for children from baseline to endline
timeFrame: This will be assessed at baseline and at endline after 12-15 months of intervention.
Other outcomes:
Locations:
city: Chennai
country: India
facility: Institute for Financial Management and Research (IFMR) and Cuddalore district, Tamil Nadu
state: Tamil Nadu
Study officials:
affiliation: Stanford University
name: Norman G Miller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Aprajit Mahajan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Pompeu Fabra
name: Alessandro Tarozzi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Reynaldo Martorell, PhD
role: PRINCIPAL_INVESTIGATOR
References: