A comparative study to evaluate the efficacy and tolerability of new generations of iron preparations with traditional iron therapy in pediatrics: A prospective randomized controlled trial.
Phase 4
- Conditions
- Haematological DisordersNutritional, Metabolic, EndocrinePaediatrics
- Registration Number
- PACTR202404915122192
- Lead Sponsor
- Menoufia faculty of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
Age range 6 months till 59 months old
no evidence of infection and negative c–reactive protein (CRP)
hemoglobin below the WHO stipulated cutoff values to define IDA anemia: hemoglobin <11.0 g/dL, MCV <73 fL and serum ferritin < 12 mg/L.
no history of consumption of iron supplements for 4 months ago or history of blood transfusion.
Exclusion Criteria
Children who had any signs of infection (fever, vomiting or diarrhea) on blood collection days,
children with anemia rather than IDA e.g. hemolytic anemia or haemoglobinopathy (sickle cell disease, beta thalassemia major)
children with chronic diseases or drugs that may affect iron absorption
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to compare the efficacy and tolerability of oral iron polymaltose complex, Micro dispersed iron, sun active iron, liposomal iron, sucrosomial iron, and iron bisglycinate chelate in treatment of IDA in preschool children aged 6-59 months.
- Secondary Outcome Measures
Name Time Method to compare their effect on growth.