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临床试验/NCT06536153
NCT06536153尚未招募3 期

Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia in Northern Zone of Sidama Region, Ethiopia.

Hawassa University0 个研究点目标入组 306 人开始时间: 2024年8月10日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
入组人数
306
主要终点
Prevalence of under-nutrition

研究概览

简要总结

Introduction: In Ethiopia, maternal malnutrition is a severe public health issue. Underweight and anaemia are the two most common nutritional problems in pregnant women, and they often coexist.

Methods: A community-based cross-sectional study will be undertaken on a sample of 528 pregnant women in their first trimester to investigate the prevalence of anemia and associated risk factors, as well as the prevalence of co-existing anemia and undernutrition. Following that, a six-month parallel-group community-based randomized controlled trial will be conducted among 306 anemic women to assess the effect of locally prepared amaranth grain flatbread on hemoglobin concentration and anemia prevalence when compared to maize bread, which is commonly consumed among pregnant women.

详细描述

Introduction

In Ethiopia, maternal malnutrition is a major public health concern. Underweight and anaemia are the two most common nutritional disorders in pregnant women, and they frequently co-exist. A prevalent kind of nutritional anaemia is iron-deficiency anaemia (IDA). These issues are primarily caused by a lack of important micro and macronutrients in the diet, as pregnant women eat primarily cereal-based foods. As a result, the burden of under-nutrition in Ethiopia necessitates a more in-depth investigation of underused crops that are high in nutrients and have the potential to minimize food and nutrition insecurity. Although the amaranth plant grows widely in Ethiopia and can boost food intake, its nutritional potential has yet to be acknowledged by community consumers and health professionals.

Methods: A community-based cross-sectional study will be conducted on a sample of 528 pregnant women in their first trimester to examine the prevalence of anemia and identify its risk factors and determine the prevalence of co-existing anemia and under-nutrition among pregnant women. From pregnant women who will be diagnosed for anemia, C-reactive protein (CRP) and serum ferritin will be analyzed to determine IDA. Following this, a parallel-group community-based randomized controlled trial will be conducted for six months among 306 anemic women to evaluate the effect of locally prepared amaranth grain flat-bread on hemoglobin concentration and anemia prevalence compared to the frequently consumed maize bread among pregnant women. A multi-stage sampling method will be utilized to select eligible pregnant women. The households with pregnant women will be identified by conducting the house-to-house census.For categorical variables, summary measures will be presented as absolute frequencies and percentages, but for numerical variables, the mean with standard deviation (SD) will be utilized as a descriptive measure after the distribution is checked for normality. A multi-level mixed-effect logistic/linear regression model will be used to account for between and with cluster effects. We will be used intention-to-treat analyses approach.

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, Care Provider, Outcomes Assessor)

盲法说明

The trial subjects, bread distributors, and outcome assessors (data collectors) will be all unaware of the study groups assignment and bread content. The bread distributers for the maize and amaranth groups will be distinct, and there will be 12 bread-distributers, one for each kebele. Twelve boxes, one for each kebele, will be packed and tagged with the name of the pregnant women. Every day, each bread-distributer fed the pregnant women at their home, under their close supervision. Unopened bread will be returned and recorded by the coordinator each day in the event of absences or refusals.

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

  • Pregnant women less than 3 months of gestational age and residing in the district for at least 6 months.

排除标准

  • Women who have a severe illness during the data collection period
  • Women who have a psychiatric disorder
  • Women who have plan to change residence during the implementation of an intervention
  • Women who have chronic diseases like tuberculosis, HIV/AIDS, and cancer
  • women who received blood transfusion in the last 6 months
  • Women who have had malaria at least 3 times in the last 3 months
  • Women with severe anemia (<7 g/dl) detected during the survey

结局指标

主要结局

Prevalence of under-nutrition

时间窗: Up to six months

In this study, the MUAC measurements of pregnant mothers who fall below a cutoff point of 23 cm will be classified as undernourished, while those who measure 23 cm or more will be classified as normal.

Prevalence of anemia

时间窗: Up to six months

In pregnancy, anemia is defined as Hemoglobin \<11 g/dl and is classified into three categories based on WHO criteria: mild (10.0-10.9 g/dl), moderate (7.0-9.9 g/dl), and severe (7.0 g/dl)

次要结局

未报告次要终点

研究者

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

Amanuel Yoseph Samago

Principal Investigator

Hawassa University

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