Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536153
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia in Northern Zone of Sidama Region Ethiopia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 censusFor 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 logisticlinear regression model will be used to account for between and with cluster effects We will be used intention-to-treat analyses approach
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 censusFor 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 logisticlinear regression model will be used to account for between and with cluster effects We will be used intention-to-treat analyses approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None