Iron-Biofortified Beans Intervention in Mexico
Condition: Iron-deficiency; Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

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.
    

Intervention name(s): Iron-biofortified beans; Control beans
Intervention type(s): Other; Other
Intervention description(s): Iron-biofortified beans (Phaseolus vulgaris L MIB465); Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size
Other intervention name(s): Fe-Beans; Control-Beans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Iron; Biofortification; Iron deficiency; Anemia; Children; Mexico