Nutritional Educational Program On Therapy in Iron Deficiency Anemia (NEPOT-IDA)

Hawler Medical University

Status: Active, not recruiting

Conditions: Growth Retardation; Nutrition Disorders; Iron Deficiency Anemia (IDA)

Treatments: Other: Educational program +Oral Iron therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06642337

HawlerMUErbil

Details and patient eligibility

About

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 children's 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.

Full 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 (e.g., vitamin C-rich foods).

Avoidance of dietary inhibitors that reduce iron absorption (e.g., 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 children's 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.

Enrollment: 150 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children aged 1 year to 5 years.
2. Confirmed diagnosis of iron deficiency anemia (hemoglobin <11 g/dL).
3. A responsible caregiver must provide written informed consent for participation.
4. No acute or chronic illnesses affecting study outcomes.
5. Reside in the study area with access to participating healthcare facilities.

Exclusion criteria

1. Any child who has received iron supplementation or blood transfusions in the past 3 months.
2. Diagnosis of any anemia other than iron deficiency anemia.
3. Known severe allergic reactions to iron supplements.
4. Caregivers unable or unwilling to comply with study protocols.
5. Current use of medications affecting iron metabolism.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Nutritional Education

Experimental group

Description:

Participants in this arm will receive a Nutritional Educational Program designed specifically for caregivers of children diagnosed with iron deficiency anemia. This program includes a series of interactive sessions that focus on the following key components: Understanding Iron Deficiency Anemia: Caregivers will learn about the causes, symptoms, and health implications of iron deficiency anemia in children. Nutritional Education: The program will provide comprehensive information on identifying and incorporating iron-rich foods into the child's diet, including meats, leafy greens, legumes, and fortified cereals. Enhancing Iron Absorption: Caregivers will be educated on dietary strategies to improve iron absorption, such as consuming vitamin C-rich foods alongside iron sources and avoiding inhibitors like calcium and certain beverages during meals. Meal Planning and Preparation: Practical guidance will be given on how to effectively plan and prepare meals that are rich in iron and other

Treatment:

Other: Educational program +Oral Iron therapy

Oral Iron Therapy

Experimental group

Description:

Participants in this arm will receive oral iron therapy as the standard treatment for iron deficiency anemia. The intervention will include the following components: Prescription of Oral Iron Supplement: Participants will be prescribed a specific oral iron formulation, such as ferrous sulfate, ferrous fumarate, or ferrous gluconate, according to established clinical guidelines tailored to the child's age and severity of anemia. Dosage and Administration: Caregivers will receive clear instructions regarding the appropriate dosage, which will be determined based on the child's weight and medical needs. Administration guidelines will include taking the iron supplement on an empty stomach for optimal absorption, unless otherwise advised by a healthcare provider. Monitoring of Adherence and Response: Caregivers will be instructed on the importance of adherence to the prescribed regimen, with scheduled follow-up visits to monitor hemoglobin levels and assess the child's overall health and r

Treatment:

Other: Educational program +Oral Iron therapy