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CompletedNCT03835377Updated Feb 19, 2019

Iron-Biofortified Beans Intervention in Mexico

An interventional study of Iron-biofortified beans and Control beans in Iron-deficiency and Anemia, sponsored by Cornell University. Completed at 1 site in Mexico. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-19.

Sponsored by Cornell University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 years after the study started (first participant enrolled Jan 2010, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
574
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Iron-deficiency
  • Anemia

Keywords

  • Iron
  • Biofortification
  • Iron deficiency
  • Anemia
  • Children
  • Mexico
03

In context

Anemia, Iron-Deficiency

660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.

This study's enrollment of 574 is above the median of 100 across 515 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Cornell University is the lead sponsor of 103 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • A prevalence of anemia \<15.0% on the baseline survey
  • Inadequate infrastructure to sustain a 6-month feeding trial
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
574 participants (actual)

Study arms

  • Experimental
    Iron-biofortified beans

    Iron-biofortified beans (Phaseolus vulgaris L MIB465)

    Other: Iron-biofortified beans

  • Active comparator
    Control beans

    Control beans (Phaseolus vulgaris L Jamapa variety)

    Other: Control beans

Interventions

  • OtherIron-biofortified beans

    Iron-biofortified beans (Phaseolus vulgaris L MIB465)

    Also known as: Fe-Beans

  • OtherControl beans

    Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size

    Also known as: Control-Beans

06

What researchers measure

Primary outcomes

  1. Change in hemoglobin

    Hemoglobin (Hb)

    Time frame: 6 months

  2. Change in serum ferritin

    Serum ferritin (SF)

    Time frame: 6 months

  3. Change in sTfR

    Soluble transferrin receptor (sTfR)

    Time frame: 6 months

  4. Anemia

    Hb \<115 g/L for \<12 y; \<120 g/L for \>=12 y

    Time frame: 6 months

  5. Iron deficiency (SF)

    Serum ferritin \<15.0 µg/L

    Time frame: 6 months

Secondary outcomes

  1. Change in TBI

    Total body iron (TBI)

    Time frame: 6 months

  2. Iron deficiency (TBI)

    TBI \<0.0 mg/kg

    Time frame: 6 months

  3. Iron deficiency (sTfr)

    sTfr \>8.3 μg/mL

    Time frame: 6 months

07

Study locations

1 site
  • Instituto Nacional de Salud Publica (INSP)
    Cuernavaca, Morelos, Mexico
08

References and documents

Publications

  • 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. PubMed 30759887 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2010 to primary completion in Jun 2010, 5 months.

Of 127 non-industry interventional studies with no phase under Anemia, Iron-Deficiency, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 27. This study's 5 months is below that.

Counting every sponsor, half of 139 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2019
First posted
Feb 8, 2019
StartActual
Jan 6, 2010
Primary completionActual
Jun 25, 2010
CompletionActual
Aug 15, 2010
Last update
Feb 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03835377
Lead sponsor
Cornell University
Collaborators
Instituto Nacional de Salud Publica, Mexico
Responsible party
Sponsor
First posted
Feb 8, 2019
Start date
Jan 6, 2010
Primary completion
Jun 25, 2010
Completion
Aug 15, 2010
Last update
Feb 19, 2019

Study contacts

Salvador Villalpando, MD PhD
principal investigator · Instituto Nacional de Salud Publica (INSP)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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