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临床试验/NCT04623918
NCT04623918已完成不适用

Randomized Trial of Iron-Biofortified Rice in Women in the Philippines

Cornell University2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2002年6月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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