Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia

NCT ID: NCT06631612

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-31

Brief Summary

The goal of this clinical trial is to learn if giving iron supplementation every other day is as effective as giving it daily in children with Iron Deficiency Anemia.

The main questions it aims to answer are:

1. Will alternate day regimen improve hemoglobin and iron profile just as well as daily dose?

2. Which group will suffer less side effects from Iron Supplementation?

Participants will be divided into two groups:

Group A: will receive oral Iron supplementation daily for 2 months Group B: will receive oral Iron supplementation every other day for 2 months Participants will be monitored using weekly phone calls to insure compliance and report side effects.

Both groups will be given Albendazole 400 mg once at the beginning of the study to be repeated in 1 week

Detailed Description

Children will be recruited from the pediatrics general clinic in Al Demerdash Hospital.

After checking fro inclusion and exclusion criteria and signing the informed consent form the following will be carried out.

1-History taking: Caregivers will be asked about:

1. Sociodemographic data: using a self-structured questionnaire

• Age of the child
• Gender of the child
• Order of birth
• Consanguinity
• Mode of delivery (either vaginal delivery or by c-section)
• Age of the mother and father
• Level of education or the mother and father
• Address of the family

2. Questions about risk factors for iron deficiency anemia/ to exclude other causes of anemia:

• Prematurity / low birth weight.
• Duration of exclusive breast feeding
• Consumption of cow milk before 1 year of age/excessive consumption of cow milk
• Mother's iron status during pregnancy
• family history for hemolytic anemias or regular blood transfusions.
• history of blood transfusions (or hemolysis: pallor ,jaundice, dark urine,anemia)
• History of chronic illness (Cardiac, hepatic or renal patients).
• History of chronic blood loss

3. Questions about symptoms of iron deficiency anemia:

Headache, lack of concentration,fatigue, palpitations, irritability,fainting, wanting to eat odd substances such as dirt or ice (also called pica),,,,etc.

2-Examination:

General examination:

1. Anthropometric measures (weight,height,BMI).

2. Look for signs of anemia: Pallor, brittle hair and nails,angular stomatitis,glossitis, Koilonychia or spooning of nails, tachycardia, hyperdynamic circulation.

3. Abdominal examination: look for tenderness, masses or hepatosplenomegaly. 3-Investigations: (a blood sample of about 5 ml will be drawn twice, once at presentation and again after 8 weeks) Complete Blood Picture (CBC) Iron profile: serum iron, TIBC. Participants will be divided into two groups.

Both groups will receive:

1. Health education regarding IDA including:

Prenatal and postnatal nutrition, the definition of anemia, diagnosis of anemia, factors causing anemia, sources of heme and non-heme iron, foods and nutrients that interfere with and promote iron absorption, and the impact of anemia on toddlers. Also food sources high in nutrients and processing high iron content of complementary breastfeeding.

2. Treatment for parasitic infections (deworming ) Albendazole 400 mg once.

Then:

Group (1) will receive daily dose of 3 mg/kg ferrous fumarate before bed. Group (2) will receive a dose of 6mg/kg ferrous fumarate before bed every other day with a maximum dose of 180 mg /day.

Participants will be dedicated to the study for 8 weeks. During this time, they will be monitored using weekly phone calls to:

1. Reinforce the health education message.

2. make sure they are compliant to their treatment.

3. monitor if any new symptoms or side effects appear.

• Outcomes:

Participants will be followed for 8 weeks. Check in after 8 weeks to repeat hemoglobin levels and serum Iron and TIBC.

Conditions

Iron Deficiency Anemia Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

daily dose of Iron Supplementation

daily dose of 3 mg/kg elemental Iron before bed

Group Type: ACTIVE_COMPARATOR

ferric hydroxide polymaltose complex

Intervention Type: DRUG

participants will receive oral iron supplementation dose according to body weight daily

Albendazole.

Intervention Type: DRUG

both arms will receive Albendazole 400mg once at the beginning f the study to be repeated after 1 week

alternate day regimen

every other day dose of 3mg/kg elemental Iron before bed

Group Type: EXPERIMENTAL

ferric hydroxide polymaltose complex

Intervention Type: DRUG

participants will receive oral iron supplementation according to body weight every other day

Albendazole.

Intervention Type: DRUG

both arms will receive Albendazole 400mg once at the beginning f the study to be repeated after 1 week

Interventions

ferric hydroxide polymaltose complex

participants will receive oral iron supplementation according to body weight every other day

Intervention Type: DRUG

ferric hydroxide polymaltose complex

participants will receive oral iron supplementation dose according to body weight daily

Intervention Type: DRUG

Albendazole.

both arms will receive Albendazole 400mg once at the beginning f the study to be repeated after 1 week

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

children 2-12 years of age diagnosed wit Iron Deficiency anemia according to WHO criteria (hemoglobin below 11 g/dl and transferrin saturation below 16%)

Exclusion Criteria

1. Children already being treated for iron deficiency anemia

2. Children known to have hemolytic anemias

3. Children with GIT disorders that prevent iron absorption (Inflammatory bowel disease,celiac disease …etc)

4. Children with chronic diseases (heart disease,liver disease,kidney disease, endocrinological disease).

5. Children who are underweight or morbidly obese

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Omnya atef Mahmoud Abdelbaky

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wessam A Professor, MD

Role: STUDY_DIRECTOR

Ain Shams Pediatrics Hospital

Locations

Ain Shams University Hospitals

Cairo, Abaseya, Egypt

Countries

Egypt

Other Identifiers

FMASU MD288/2023

Identifier Type: -

Identifier Source: org_study_id