跳至主要内容
临床试验/NCT03835377
NCT03835377已完成不适用

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

Cornell University1 个研究点 分布在 1 个国家目标入组 574 人开始时间: 2010年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
574
试验地点
1
主要终点
Change in serum ferritin

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

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

研究组 & 干预措施

Iron-biofortified beans

Experimental

Iron-biofortified beans (Phaseolus vulgaris L MIB465)

干预措施: Iron-biofortified beans (Other)

Control beans

Active Comparator

Control beans (Phaseolus vulgaris L Jamapa variety)

干预措施: Control beans (Other)

结局指标

主要结局

Change in serum ferritin

时间窗: 6 months

Serum ferritin (SF)

Anemia

时间窗: 6 months

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

Iron deficiency (SF)

时间窗: 6 months

Serum ferritin \<15.0 µg/L

Change in hemoglobin

时间窗: 6 months

Hemoglobin (Hb)

Change in sTfR

时间窗: 6 months

Soluble transferrin receptor (sTfR)

次要结局

  • Iron deficiency (sTfr)(6 months)
  • Change in TBI(6 months)
  • Iron deficiency (TBI)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验