Clinical trial NCT06642337: Nutritional Educational Program On Therapy in Iron Deficiency Anemia
Official title: Effectiveness of Nutritional Educational Program on Caregiver's Knowledge and Performance Versus Oral Iron Therapy Alone on Hemoglobin Level Among Children With Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Iron Deficiency Anemia (IDA)
Nutrition Disorders
Growth Retardation
Keywords: Iron Deficiency Anemia
Pediatric Anemia
Oral Iron Therapy
Nutritional Education
Caregiver Knowledge
Hemoglobin Levels
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 (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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hemoglobin Levels
timeFrame: 3 months (Measured at baseline and at the conclusion of the study).
Secondary outcomes:
measure: Improvement in Caregivers' Knowledge of Iron-Rich Foods
timeFrame: Before the educational intervention and 3 months post-intervention.
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University/College of nursing
state: Kurdistan Region, Iraq
Study officials:
References:
citation: Chandra J, Dewan P, Kumar P, Mahajan A, Singh P, Dhingra B, Radhakrishnan N, Sharma R, Manglani M, Rawat AK, Gupta P, Gomber S, Bhat S, Gaikwad P, Elizabeth KE, Bansal D, Dubey AP, Shah N, Kini P, Trehan A, Datta K, Basavraja GV, Saxena V, Kumar RR. Diagnosis, Treatment and Prevention of Nutritional Anemia in Children: Recommendations of the Joint Committee of Pediatric Hematology-Oncology Chapter and Pediatric and Adolescent Nutrition Society of the Indian Academy of Pediatrics. Indian Pediatr. 2022 Oct 15;59(10):782-801.
citation: da Silva Lopes K, Yamaji N, Rahman MO, Suto M, Takemoto Y, Garcia-Casal MN, Ota E. Nutrition-specific interventions for preventing and controlling anaemia throughout the life cycle: an overview of systematic reviews. Cochrane Database Syst Rev. 2021 Sep 26;9(9):CD013092. doi: 10.1002/14651858.CD013092.pub2.