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Iron-Biofortified Beans Intervention in Mexico

Primary Purpose

Iron-deficiency, Anemia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Iron-biofortified beans
Control beans
Sponsored by
Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron-deficiency focused on measuring Iron, Biofortification, Iron deficiency, Anemia, Children, Mexico

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Nacional de Salud Publica (INSP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iron-biofortified beans

Control beans

Arm Description

Iron-biofortified beans (Phaseolus vulgaris L MIB465)

Control beans (Phaseolus vulgaris L Jamapa variety)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in TBI
Total body iron (TBI)
Iron deficiency (TBI)
TBI <0.0 mg/kg
Iron deficiency (sTfr)
sTfr >8.3 μg/mL

Full Information

First Posted
January 11, 2019
Last Updated
February 18, 2019
Sponsor
Cornell University
Collaborators
Instituto Nacional de Salud Publica, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03835377
Brief Title
Iron-Biofortified Beans Intervention in Mexico
Official Title
A Randomized Feeding Trial of Iron-Biofortified Beans in School Children in Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 6, 2010 (Actual)
Primary Completion Date
June 25, 2010 (Actual)
Study Completion Date
August 15, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
Instituto Nacional de Salud Publica, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Anemia
Keywords
Iron, Biofortification, Iron deficiency, Anemia, Children, Mexico

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The study was a double-blind, cluster-randomized controlled trial (with randomization at the school level) of: (1) iron-biofortified black beans, compared to (2) a commercial variety of beans, with the intervention randomized at the school level. School administrators, children, research staff (i.e. managing the intervention, food weighing, assessment of outcomes), and laboratory staff were blinded to the intervention group.
Allocation
Randomized
Enrollment
574 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iron-biofortified beans
Arm Type
Experimental
Arm Description
Iron-biofortified beans (Phaseolus vulgaris L MIB465)
Arm Title
Control beans
Arm Type
Active Comparator
Arm Description
Control beans (Phaseolus vulgaris L Jamapa variety)
Intervention Type
Other
Intervention Name(s)
Iron-biofortified beans
Other Intervention Name(s)
Fe-Beans
Intervention Description
Iron-biofortified beans (Phaseolus vulgaris L MIB465)
Intervention Type
Other
Intervention Name(s)
Control beans
Other Intervention Name(s)
Control-Beans
Intervention Description
Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size
Primary Outcome Measure Information:
Title
Change in hemoglobin
Description
Hemoglobin (Hb)
Time Frame
6 months
Title
Change in serum ferritin
Description
Serum ferritin (SF)
Time Frame
6 months
Title
Change in sTfR
Description
Soluble transferrin receptor (sTfR)
Time Frame
6 months
Title
Anemia
Description
Hb <115 g/L for <12 y; <120 g/L for >=12 y
Time Frame
6 months
Title
Iron deficiency (SF)
Description
Serum ferritin <15.0 µg/L
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in TBI
Description
Total body iron (TBI)
Time Frame
6 months
Title
Iron deficiency (TBI)
Description
TBI <0.0 mg/kg
Time Frame
6 months
Title
Iron deficiency (sTfr)
Description
sTfr >8.3 μg/mL
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvador Villalpando, MD PhD
Organizational Affiliation
Instituto Nacional de Salud Publica (INSP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Salud Publica (INSP)
City
Cuernavaca
State/Province
Morelos
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30759887
Citation
Finkelstein JL, Mehta S, Villalpando S, Mundo-Rosas V, Luna SV, Rahn M, Shamah-Levy T, Beebe SE, Haas JD. A Randomized Feeding Trial of Iron-Biofortified Beans on School Children in Mexico. Nutrients. 2019 Feb 12;11(2):381. doi: 10.3390/nu11020381.
Results Reference
derived

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Iron-Biofortified Beans Intervention in Mexico

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