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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:
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
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:
Sociodemographic data: using a self-structured questionnaire
Questions about risk factors for iron deficiency anemia/ to exclude other causes of anemia:
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:
Both groups will receive:
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.
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:
Reinforce the health education message.
make sure they are compliant to their treatment.
monitor if any new symptoms or side effects appear.
Participants will be followed for 8 weeks. Check in after 8 weeks to repeat hemoglobin levels and serum Iron and TIBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daily dose of Iron Supplementation | Active Comparator | daily dose of 3 mg/kg elemental Iron before bed |
|
| alternate day regimen | Experimental | every other day dose of 3mg/kg elemental Iron before bed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferric hydroxide polymaltose complex | Drug | participants will receive oral iron supplementation according to body weight every other day |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in hemoglobin | treatment will be considered successful if there is an increase of hemoglobin at least 1 g/dl every 4 weeks | 8 weeks |
| change in Iron Profile | changes in serum Iron will be compared between the two groups | 8 weeks |
| change in iron profile | change in TIBC will be compared between the two groups | 8 weeks |
| change in iron profile | change in transferrin saturation will be compared between the two groups | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of side effects | frequency of different side effects (eg: abdominal pain, nausea, vomitting , etc.)will be compared between the two groups | 8 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Wessam A Professor, MD | Ain Shams Pediatrics Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Abaseya | Egypt |
all data collected and used in the results will be shared
start date: June 2025 end date: June 2026
Anyone can access the IPD plan including the excel sheet of data collection and what type of analysis was used.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| ferric hydroxide polymaltose complex | Drug | participants will receive oral iron supplementation dose according to body weight daily |
|
| Albendazole. | Drug | both arms will receive Albendazole 400mg once at the beginning f the study to be repeated after 1 week |
|
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |