Nutritional Educational Program On Therapy in Iron Deficiency Anemia

NCT06642337 | Active Not Recruiting DMC

• 1 other identifier: HawlerMUErbil
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Does caregiver education improve children's hemoglobin levels more effectively than oral iron therapy alone?
2. 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.

Conditions

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

Keywords

Iron Deficiency Anemia; Pediatric Anemia; Oral Iron Therapy; Nutritional Education; Caregiver Knowledge; Hemoglobin Levels

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin Levels

  His outcome measure aims to assess the difference in hemoglobin levels in children diagnosed with iron deficiency anemia at the beginning of the study compared to their levels at the end of the intervention. The study will compare the effectiveness of oral iron therapy alone versus oral iron therapy combined with a Nutritional Educational Program provided to caregivers. Hemoglobin levels will be evaluated through blood tests, providing a quantitative assessment of the interventions' impact on anemia.

  3 months (Measured at baseline and at the conclusion of the study).

Secondary Outcomes (1)

• Improvement in Caregivers' Knowledge of Iron-Rich Foods

  Before the educational intervention and 3 months post-intervention.

Study Arms (2)

Nutritional Education

EXPERIMENTAL

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

Other: Educational program +Oral Iron therapy

Oral Iron Therapy

EXPERIMENTAL

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

Other: Educational program +Oral Iron therapy

Interventions

Educational program +Oral Iron therapy OTHER

The Nutritional Education Program is a structured intervention designed to enhance caregivers' understanding of nutrition and improve dietary practices for children suffering from iron deficiency anemia. The program comprises six weekly workshops lasting 1.5 hours each, focusing on essential topics such as the importance of iron in child development, identifying and preparing iron-rich foods, and practical meal planning strategies. Participants will engage in hands-on cooking demonstrations and receive educational materials, including recipe cards and meal planning tools, to support their learning. Knowledge assessments will be conducted at the beginning and end of the program to measure improvements in caregivers' nutritional knowledge.

Also known as: Nutritional Education Program

Nutritional Education; Oral Iron Therapy

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Medical University/College of nursing

Erbil, Kurdistan Region, Iraq, 44001, Iraq

Location

Related Publications (2)

• 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.

  PMID: 36263494 BACKGROUND

• 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.

  PMID: 34564844 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Nutrition Disorders

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc In Pediatric Nursing

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: February 1, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)