Iron-Biofortified Beans Intervention in Mexico

February 18, 2019 updated by: Cornell University

A Randomized Feeding Trial of Iron-Biofortified Beans in School Children in Mexico

The objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans). A cluster-randomized trial of biofortified beans (Phaseolus vulgaris L), bred to enhance iron content, was conducted for 6 months.

Study Overview

Status

Completed

Conditions

Detailed Description

Iron deficiency is the most common single nutrient deficiency worldwide, with the highest burden in children and women of reproductive age. Global estimates of anemia prevalence in school-aged children range between 25% and 46%, and iron deficiency accounts for a majority of anemia cases. In Mexico, the national nutrition and health survey (2006) reported a prevalence of anemia of 16.6% and iron deficiency of 17.6% (serum ferritin <12.0 µg/L), posing a considerable health risk for children.

Interventions, including micronutrient supplementation and food fortification, have improved iron status and reduced the prevalence of anemia in some settings. However, iron deficiency remains an urgent public health problem and threat to child health and development. Young children are particularly at high risk due to rapid growth, inadequate dietary intake, and high risk of infection in resource-limited settings. Iron deficiency has been associated with impaired cognitive function in children, and long-term impairments in physical work capacity into adulthood.

One novel approach to reducing micronutrient malnutrition is to enhance the nutrient quality of the diet through biofortification of staple crops that are already locally accepted and consumed. Biofortification has consequently been recognized by the Copenhagen Consensus of 2008 as one of the top five solutions to current global health and nutrition challenges. The success and challenges of biofortification have been documented previously. We recently reviewed the published evidence from the three randomized efficacy trials of different iron-biofortified crops that demonstrated varied benefits in populations, including rice in adult Filipino women, pearl millet in school-aged children in India, and beans in women of reproductive age in Rwanda. Findings demonstrated improvements in serum ferritin concentrations and total body iron concentrations, with additional potential to benefit in individuals who were iron deficient at baseline. Given this limited evidence and with no studies from Latin America, more studies with diverse populations and locally relevant crops are warranted before implementation of a potentially important public health intervention.

In order to target at-risk populations in Latin America, the Centro Internacional de Agricultura Tropical (CIAT) in Colombia bred and biofortified a common black bean variety (Phaseolus vulgaris L), the standard black bean currently consumed widely in Central America and Mexico. In Mexico, beans have been ranked highly among the most consumed foods by school-aged children nationwide, according to Encuesta Nacional de Salud y Nutrición, a nationally representative nutrition survey in 2006. Biofortification has nearly doubled the iron concentration (~100 versus ~50 mg/kg) of the standard bean variety. We hypothesized that daily consumption of iron-biofortified beans (Fe-Beans) would improve hemoglobin, serum ferritin, and total body iron in 6 months, compared to control beans (Control-Beans). In order to examine this hypothesis, we conducted the first randomized efficacy trial of iron-biofortified beans and iron status in primary school-aged children in a low-income setting in Mexico. Special consideration was applied to assess indicators of iron status with and without anemia and measured inflammatory markers, which can mask iron deficiency, particularly in similar settings where the prevalence of infection is high.

The objective of this cluster-randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified beans (Fe-Beans) on iron status in children, compared to control beans (Control-Beans).

The long-term goal of this study is to determine if iron bio-fortification of beans is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.

Study Type

Interventional

Enrollment (Actual)

574

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Instituto Nacional de Salud Pública (INSP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Boarding schools for children (5-12 y)
  • Located in a rural area approximately 60 kilometers east of the city of Oaxaca
  • A high prevalence of anemia (>=15.0%) on the baseline survey
  • Adequate infrastructure to sustain a 6-month feeding trial. Exclusion criteria were a prevalence of anemia of less than 15% on the baseline survey, and inadequate infrastructure to sustain a 6-month feeding trial

Exclusion Criteria:

  • A prevalence of anemia <15.0% on the baseline survey
  • Inadequate infrastructure to sustain a 6-month feeding trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Iron-biofortified beans
Iron-biofortified beans (Phaseolus vulgaris L MIB465)
Iron-biofortified beans (Phaseolus vulgaris L MIB465)
Other Names:
  • Fe-Beans
ACTIVE_COMPARATOR: Control beans
Control beans (Phaseolus vulgaris L Jamapa variety)
Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size
Other Names:
  • Control-Beans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hemoglobin
Time Frame: 6 months
Hemoglobin (Hb)
6 months
Change in serum ferritin
Time Frame: 6 months
Serum ferritin (SF)
6 months
Change in sTfR
Time Frame: 6 months
Soluble transferrin receptor (sTfR)
6 months
Anemia
Time Frame: 6 months
Hb <115 g/L for <12 y; <120 g/L for >=12 y
6 months
Iron deficiency (SF)
Time Frame: 6 months
Serum ferritin <15.0 µg/L
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TBI
Time Frame: 6 months
Total body iron (TBI)
6 months
Iron deficiency (TBI)
Time Frame: 6 months
TBI <0.0 mg/kg
6 months
Iron deficiency (sTfr)
Time Frame: 6 months
sTfr >8.3 μg/mL
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Salvador Villalpando, MD PhD, Instituto Nacional de Salud Pública (INSP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 6, 2010

Primary Completion (ACTUAL)

June 25, 2010

Study Completion (ACTUAL)

August 15, 2010

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (ACTUAL)

February 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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