Clinical trial NCT06536153: Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia
Official title: Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia in Northern Zone of Sidama Region, Ethiopia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Maternal Anemia in Pregnancy, Before Birth
Maternal; Malnutrition, Affecting Fetus
Keywords: Pregnant women
Undernutrition
Anemia
Amaranth grain
Sidama region
Ethiopia
Lead sponsor: Hawassa University
Sponsor class: OTHER
Collaborators: name: Nestlé Foundation
First posted: 2024-08-02
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both bi-variable and multivariable analyses using multilevel mixed effects modified Poisson models with random effects will be carried out if the outcome variable prevalence is greater than 20%. If the prevalence is less than 20%, a multilevel mixed effects binary logistic regression model will be utilized to adjust for between- and within-cluster variation for adjusted analysis.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of anemia
timeFrame: Up to six months
measure: Prevalence of under-nutrition
timeFrame: Up to six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hawassa University
name: Amanuel Yo Samago, Masters
role: PRINCIPAL_INVESTIGATOR
References: