Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642337
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Nutritional Educational Program On Therapy in Iron Deficiency Anemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Nutritional Educational Program on Caregivers Knowledge and Performance Versus Oral Iron Therapy Alone on Hemoglobin Level Among Children With Iron Deficiency Anemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
NEPOT-IDA
Brief Summary:
The goal of this clinical trial is to evaluate whether a Nutritional Educational Program for caregivers can improve their knowledge and performance in managing iron deficiency anemia IDA in children compared to oral iron therapy alone The study focuses on children with IDA particularly in age range 1-5 years and aims to determine if combining nutritional education with oral iron therapy has a greater impact on improving hemoglobin levels than iron therapy alone
The main questions it aims to answer are
1 Does caregiver education improve childrens hemoglobin levels more effectively than oral iron therapy alone
2 Does nutritional education improve caregiver knowledge and practices regarding iron-rich diets Researchers will compare children who receive both caregiver education and oral iron therapy to those receiving only oral iron therapy to assess differences in hemoglobin levels
Participants will
Receive oral iron supplements Caregivers will participate in educational sessions on dietary strategies to manage IDA
The main questions it aims to answer are
1 Does caregiver education improve childrens hemoglobin levels more effectively than oral iron therapy alone
2 Does nutritional education improve caregiver knowledge and practices regarding iron-rich diets Researchers will compare children who receive both caregiver education and oral iron therapy to those receiving only oral iron therapy to assess differences in hemoglobin levels
Participants will
Receive oral iron supplements Caregivers will participate in educational sessions on dietary strategies to manage IDA
Detailed Description:
This clinical trial aims to explore the effectiveness of a Nutritional Educational Program for caregivers in combination with oral iron therapy on improving hemoglobin levels in children with iron deficiency anemia IDA Iron deficiency is a leading cause of anemia in children and oral iron supplementation is the standard treatment However dietary habits and caregiver knowledge also play a significant role in managing this condition This study will evaluate whether equipping caregivers with nutritional education enhances the outcomes of oral iron therapy
The study will involve two groups of children with confirmed iron deficiency anemia
Intervention Group Children receiving oral iron therapy combined with a structured Nutritional Educational Program for their caregivers The educational program will cover
Understanding iron deficiency anemia and its effects on child health Identification of iron-rich foods and dietary strategies to enhance iron absorption eg vitamin C-rich foods
Avoidance of dietary inhibitors that reduce iron absorption eg calcium-rich foods and tea during meals
Guidance on meal preparation and frequency to optimize iron intake Control Group Children receiving only oral iron therapy without the nutritional education component
The primary outcome will be the change in hemoglobin levels over a specified period Secondary outcomes will include caregivers knowledge and performance measured through pre- and post-intervention questionnaires as well as adherence to the treatment regimen and dietary recommendations
Participants will attend follow-up visits where hemoglobin levels will be monitored and caregivers will be assessed for their understanding and application of the nutritional guidance provided Data on the childrens dietary intake will also be collected and analyzed
This trial aims to determine if caregiver-focused nutritional education improves the management of IDA more effectively than iron therapy alone potentially leading to better long-term health outcomes in children
The study will involve two groups of children with confirmed iron deficiency anemia
Intervention Group Children receiving oral iron therapy combined with a structured Nutritional Educational Program for their caregivers The educational program will cover
Understanding iron deficiency anemia and its effects on child health Identification of iron-rich foods and dietary strategies to enhance iron absorption eg vitamin C-rich foods
Avoidance of dietary inhibitors that reduce iron absorption eg calcium-rich foods and tea during meals
Guidance on meal preparation and frequency to optimize iron intake Control Group Children receiving only oral iron therapy without the nutritional education component
The primary outcome will be the change in hemoglobin levels over a specified period Secondary outcomes will include caregivers knowledge and performance measured through pre- and post-intervention questionnaires as well as adherence to the treatment regimen and dietary recommendations
Participants will attend follow-up visits where hemoglobin levels will be monitored and caregivers will be assessed for their understanding and application of the nutritional guidance provided Data on the childrens dietary intake will also be collected and analyzed
This trial aims to determine if caregiver-focused nutritional education improves the management of IDA more effectively than iron therapy alone potentially leading to better long-term health outcomes in children
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