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临床试验/NCT02341586
NCT02341586已完成不适用

A Randomized Control Trial of the Lucky Iron Fish to Improve Hemoglobin Concentration in Women in Preah Vihear, Cambodia

University of British Columbia1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2015年4月最近更新:
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
340
试验地点
1
主要终点
hemoglobin concentration at endline

研究概览

简要总结

The purpose of this research is to determine if cooking with an iron ingot called the Lucky Iron Fish (LIF) increases the hemoglobin status in women of childbearing age living in Preah Vihear, Cambodia. The investigators hypothesize that the use of the LIF during cooking over a 12-month period will be as efficacious at increasing hemoglobin concentration as iron supplements (18 mg elemental iron) and will be more efficacious than the control.

详细描述

Background: Anemia is prevalent in Cambodia, affecting ~44% of women. The causes of anemia are multifactorial. Globally, the most common form is iron deficiency anemia (IDA), which can lead to adverse perinatal health outcomes. In Cambodia, there is evidence that suggests hemoglobinopathies (genetic hemoglobin [Hb] disorders) are prevalent (~50%) and are a major contributor to anemia. In Preah Vihear province, Cambodia, the estimated prevalence of malaria is ~12.3%. Malaria contributes to anemia through a decrease in the production of red blood cells, and an increased destruction of red blood cells.

In Cambodia, iron supplements are recommended to treat anemia, however there is evidence of low compliance among women. The use of cast iron pots has proven to be an effective alternative to prevent and reduce IDA in developing countries. However, cast iron pots are not commonly used in Cambodia because they are expensive, difficult to clean, and heavy. A novel alternative is the Lucky Iron Fish (LIF), which is an iron ingot used during cooking as an in-home fortification system of iron transfer. The LIF ingot is small, lightweight, and easy to clean. Previous research in Cambodia confirmed the acceptance of the LIF to be high, but findings from this study were inconclusive and had several limitations.

Objective: The primary objective of this study is to determine the efficacy of the LIF to increase Hb concentration in Cambodian women of reproductive age.

Methods: A total of 330 women (18-49 y) with mild or moderate anemia (Hb 80-120 g/L) from rural Preah Vihear, Cambodia will be recruited to one of three arms to receive LIF, 18 mg elemental iron, or a placebo. Women with severe anemia will be excluded and referred for treatment. All three groups will receive nutrition education. Monitoring will be conducted monthly to measure compliance.

A trained, Khmer-speaking interviewer will meet with the women to explain the details of the study as per the consent form. Once consent is obtained the trained interviewer will measure hemoglobin status using a hemocue device to confirm eligibility of the study. If eligible, the trained interviewer will then administer the baseline questionnaire in the participant's home.

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
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Mild or Moderate Anemia [Hb 80-119]
  • Willing to provide a fingerprick sample of blood at baseline
  • Willing to provide 10 mL of venous blood at 0, 6 & 12 months
  • Not planning on moving in the next 12 months
  • Not participating in any other nutrition intervention
  • Be able to provide written and information consent

排除标准

  • Be ill or taking any medications [Hb < 80]
  • Have normal Hb status [Hb > 120]
  • Currently consuming or planning to consume Fe supplements in the next 12 months
  • Pregnant (based on self report)

研究组 & 干预措施

Control group

Other

This group will receive nutrition education

干预措施: Nutrition Education (Other)

Lucky Iron Fish

Experimental

This group will receive a Lucky Iron Fish to use during cooking.

干预措施: Lucky Iron Fish - home fortification system (Other)

18 mg iron

Active Comparator

This group will receive a daily oral iron supplement.

干预措施: 18 mg elemental iron (Dietary Supplement)

结局指标

主要结局

hemoglobin concentration at endline

时间窗: 12 months

次要结局

  • Change in soluble transferrin receptor (sTfR) concentration(Baseline (t=0), midline (t=6 months), and endline (t=12 months))
  • Change in ferritin concentration(Baseline (t=0), midline (t=6 months), and endline (t=12 months))
  • Number of women in Preah Vihear, Cambodia with a genetic hemoglobin disorder(Midline (t=6 months))
  • How the prevalence of malaria changes in women living in Preah Vihear Cambodia over one year(Baseline (t=0), midline (t=6 months), and endline (t=12 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tim Green

Principle Investigator

University of British Columbia

研究点 (1)

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