The Effect of Multiple Micronutrient Supplements in Reducing Anemia Among Women of Reproductive Age Compared to Iron-folic Acid at Kebribeyah District in Somali Regional State, Ethiopia- A Community-based Individual Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Change in overall anemia among women of reproductive age
研究概览
简要总结
The goal of this clinical trial is to test the effect of multiple micronutrient supplements in reducing anemia in women of reproductive age in comparison with iron-folic acid.
The main questions it aims to answer are:
- What is the effect of multiple micronutrient supplements in reducing anemia among women of reproductive age in comparison with iron-folic acid?
- What is the effect of multiple micronutrient supplements in reducing iron deficiency among women of reproductive age in comparison with iron-folic acid?
Participants will
- be given multiple micronutrient supplements, iron folic acid, or placebo twice weekly for 17 weeks
- be asked to respond to the interview
- provide blood, urine, and stool samples
Researchers will compare the control group with the intervention groups to see the effect of multiple micronutrient supplements on iron deficiency and anemia reduction.
详细描述
Women in developing countries are often at risk of micronutrient deficiencies due to inadequate micronutrient intake. Since various micronutrient deficiencies co-exist, multiple micronutrient supplements are recommended to combat their deficiencies. The purpose of this study is to assess the effects of multiple micronutrient supplements among women of reproductive age in reducing anemia compared with iron-folic acid as currently practiced in Ethiopia. The current study is a community-based individual randomized placebo-controlled trial. The trial is double blinded with three parallel groups. This trial will be conducted in three randomly selected kebeles (villages) in the Kebribeyah district in the Somali regional state. The sample size determined for this study is 305. There will be two intervention arms and one control arm in this trial. A third of participants will be in each arms. The intervention arms will will be supplemented with United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) or iron-folic acid (IFA) and the control arm with placebos twice a week. The investigators will follow the study participants for 17 weeks. The primary outcome is a change in mean hemoglobin concentrations and reduction in anemia prevalence. Stratified randomization will be used to assign the participants randomly to the study arms. In the current trial, the outcome assessors and study subjects will both be blinded. The supplements being administered to participants, as well as who is in the intervention group and who is in the control group, will be masked from the assessors. The trial participants will be blinded to the kind of supplements being administered to them or the group to which they were assigned. The allocation sequence of participants will be concealed from the researcher who will assign the participants to the study arms. When the eligible woman meets the screening criteria and gives informed consent, she will be assigned an envelope that contains an allocation sequence. As outcome measures, the investigators will assess the reduction in overall anemia and iron deficiency anemia attributable to the supplementation. In addition, a complete blood count (CBC) will be tested for all study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In the current trial, the outcome assessors and study subjects will both be blinded. The supplements being administered to participants, as well as who is in the intervention group and who is in the control group, will be masked from the assessors. The trial participants will be blinded to the kind of supplements being administered to them and the group to which they were assigned.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age range of 18-49 years.
- •Mildly anemic (Hb=11.0-11.9 g/dl) or moderately anemic (Hb=8.0-10.9 g/dl) woman
- •Permanent residents (lived for at least six months in the enumeration area)
排除标准
- •A woman whose age is below or above the age range 18-49 year
- •A pregnant woman
- •Severely ill and incapacitated woman
- •Non-permanent resident in the enumeration area
- •Severely anemic (Hb <8.0 g/dl) woman
- •A woman with Hb ≥12 g/dl
结局指标
主要结局
Change in overall anemia among women of reproductive age
时间窗: Blood sample will be collected once at baseline and once at end-line in four months
Anemia diagnosed when hemoglobin concentration test result is less than 12 g/dl
Change in mean hemoglobin concentrations among women of reproductive age
时间窗: Blood sample will be collected once at baseline and once at end-line in four months
Hemoglobin concentration is measured in gram/deciliter from whole blood samples collected at baseline and end-line.
次要结局
- Change in mean ferritin concentration among women of reproductive age(The serum samples will be collected once at the baseline and once at the end-line in four months)
- Change in iron deficiency anemia among women of reproductive age(Blood sample will be collected once at baseline and once at end-line in four months)
研究者
Desalegn Kuche
Researcher for nutrition
Ethiopian Public Health Institute