Ain Shams University Hospitals
Cairo, Abaseya, Egypt
NCT Number: NCT06631612
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
This study is active but is not currently recruiting participants.
Notify Me2 year–12 year
All sexes
Interventional
Phase 4
Cairo, Abaseya, Egypt
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:
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:
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.
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:
Participants will be followed for 8 weeks. Check in after 8 weeks to repeat hemoglobin levels and serum Iron and TIBC.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
participants will receive oral iron supplementation according to body weight every other day
both arms will receive Albendazole 400mg once at the beginning f the study to be repeated after 1 week
Time frame: 8 weeks
treatment will be considered successful if there is an increase of hemoglobin at least 1 g/dl every 4 weeks
Time frame: 8 weeks
changes in serum Iron will be compared between the two groups
Time frame: 8 weeks
change in TIBC will be compared between the two groups
Time frame: 8 weeks
change in transferrin saturation will be compared between the two groups
Time frame: 8 weeks
frequency of different side effects (eg: abdominal pain, nausea, vomitting , etc.)will be compared between the two groups
Ain Shams University
Other
Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia: a Hospital Based Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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