Iron Deficiency Anemia, Iron Deficiency, Anaemia in Children
Conditions
Keywords
IRON POLMALTOSE COMPLEX, FERROUS SULPHATE, Iron Deficiency, Anaemia in Children
Brief summary
This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.
Detailed description
Anemia remains a condition with high prevalence in populations worldwide. It is predominantly associated with nutritional status and socioeconomic conditions or hereditary diseases. The majority of anemia cases are linked to iron deficiency-named iron-deficiency anemia resulting from low intake of iron-rich foods in the diet, or from substantial blood loss. This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.
Interventions
DRUGFerrous sulfate
ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form.
Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.
Sponsors
Khyber Teaching Hospital
Arooj Khan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be divided randomly in two groups using blocked randomization generated by computer software.
Intervention model description
Brief history and demographic data including age, gender, duration of pallor, residence, weight, educational level of mother, socioeconomic status of father will be noted. Under aseptic techniques 5cc venous sample will be drawn and send to hospital laboratory for baseline hemoglobin and serum ferritin level. All patients will be dewormed before starting therapy by giving oral albendazole l0 ml stat dose. Patients will be divided randomly in two groups using blocked randomization generated by computer software. Group A will be given ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form. Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks. Both the groups will be called for follow up. Hemoglobin level will be assessed after 8 week of therapy.
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients having iron deficiency anemia
Exclusion criteria
1. Patients diagnosed as congenital aplastic anemia or thalassemia (Determined from medical record). 2. Patients who were transfused in previous 4 weeks (will be determined on history) 3. Children having mal-absorption syndrome and diarrheal illnesses. (will be determined on history and medical record) 4. Gastrointestinal bleeding suggested by history of hematemesis (bloody vomit), melena (black colored stools) or bloody stools.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase Of Hemoglobin Level | 8 weeks | Increase in Hemoglobin level measured by a Complete Blood Count as compared to pre treatment Hemoglobin |
Countries
Pakistan
Contacts
Primary ContactAimal Khan, MBBS
Outcome results
None listed