Randomized Trial of Iron-Biofortified Rice in Women in the Philippines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Change in sTfR
研究概览
简要总结
The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.
详细描述
Iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. In this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. Women living in convents in the greater Manila area were recruited for this study. These women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively.
The investigators hypothesized that daily consumption of iron-biofortified rice (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. In order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of Manila, Philippines for 9 months.
The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.
The long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.
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
Masking description: The study was a double-blind, randomized controlled trial of; (1) iron-biofortified rice (IR68144-2B-2-2-3), compared to (2) a commercially available variety of rice (C4), with the intervention randomized at the individual level. Administrators, participants, research staff (i.e. responsible for daily data collection and preparation of rice for all meals, assessment of outcomes), and laboratory staff were blinded to the intervention group.
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women (18-45 years old) living in convents in the greater Manila area
- •Hb ≥10.5 g/dL
排除标准
- •Current or history of gastrointestinal or hematological disorders
- •Taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption
- •Hb <10.5 g/dL
- •Women expressed uncertainty in their ability to participate for the full (9 month) trial
结局指标
主要结局
Change in sTfR
时间窗: 9 months
Soluble transferrin receptor (sTfR)
Change in serum ferritin
时间窗: 9 months
Serum ferritin (SF)
Change in TBI
时间窗: 9 months
Total body iron (TBI)
次要结局
- Changes in sTfR among women who were non-anemic at baseline(9 months)
- Change in hemoglobin among women who were anemic at baseline(9 months)
- Changes in SF among women who were non-anemic at baseline(9 months)
- Changes in TBI among women who were non-anemic at baseline(9 months)
