Iron Deficiency Anemia (IDA)NEPOT-IDANCT06642337
Nutritional Educational Program On Therapy in Iron Deficiency Anemia
A study testing Educational program in people with Iron Deficiency Anemia (IDA) and Nutrition Disorders, run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Iron Deficiency Anemia (IDA), Nutrition Disorders, Growth Retardation
- What is being tested?
- Educational program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2025to 22 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Hawler Medical University/College of nursing
Erbil, Kurdistan Region, Iraq, 44001
About this study
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
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:
Read more
- Does caregiver education improve children's hemoglobin levels more effectively than oral iron therapy alone?
- 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.
Read the 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.
- Being tested
- Educational program
- Keywords
- Iron Deficiency Anemia, Pediatric Anemia, Oral Iron Therapy, Nutritional Education, Caregiver Knowledge, Hemoglobin Levels
- Medical subject headings
- Anemia, Iron-Deficiency, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programOther
Also called Nutritional Education Program
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 three weeks person by person interview lasting 25 Mins 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Educational program |
| 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 Receives: Other: Educational program |
| Oral Iron Therapy + Nutritional Education | Experimental | Both above information Oral Iron Therapy + Nutritional Education Receives: Other: Educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months (Measured at baseline and at the conclusion of the study).
Secondary outcomes (1)
Improvement in Caregivers' Knowledge of Iron-Rich Foods
This measure will evaluate the change in caregivers' knowledge regarding dietary management of iron deficiency anemia before and after the Nutritional Educational Program. The assessment will be conducted using a validated questionnaire that gauges understanding of iron-rich foods, dietary sources, and practices that enhance iron absorption.
Measured: Before the educational intervention and 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Feb 2025
- Primary completion15 Sep 2026
- Study completion22 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia (IDA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMANJ YASSIN HAMAD AMIN, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642337
- Sponsor's protocol ID
- HawlerMUErbil
- Acronym
- NEPOT-IDA
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36263494da 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.
PubMed 34564844
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06642337
- Acronym / sponsor ID
- NEPOT-IDA / HawlerMUErbil
- Keywords
- Iron Deficiency Anemia, Pediatric Anemia, Oral Iron Therapy, Nutritional Education, Caregiver Knowledge, Hemoglobin Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 22 Sep 2026 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does caregiver education improve children's hemoglobin levels more effectively than oral iron therapy alone?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutritional Education | Experimental | Other: Educational programParticipants 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 |
| Oral Iron Therapy | Experimental | Other: Educational programParticipants 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 |
| Oral Iron Therapy + Nutritional Education | Experimental | Other: Educational programBoth above information Oral Iron Therapy + Nutritional Education |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programAlso: Nutritional Education ProgramThe 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 three weeks person by person interview lasting 25 Mins 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. | Other | Nutritional Education, Oral Iron Therapy, Oral Iron Therapy + Nutritional Education |
Primary outcome
Change in Hemoglobin Levels
Time frame: 3 months (Measured at baseline and at the conclusion of the study).
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.
1 secondary outcome
Improvement in Caregivers' Knowledge of Iron-Rich Foods
Time frame: Before the educational intervention and 3 months post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 36263494Chandra 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.
- Background: PubMed 34564844da 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Iron Deficiency Anemia (IDA) and Nutrition Disorders, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Levels (time frame: 3 months (Measured at baseline and at the conclusion of the study).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.