Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients

Arooj Khan

Status: Enrolling

Conditions: Iron Deficiency Anemia; Iron Deficiency, Anaemia in Children

Treatments: Drug: Ferrous sulfate; Drug: Iron Polymaltose Complex

Study type: Interventional

Funder types: Other

Identifiers

NCT06742528

591/DME/KMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

198 participants in 2 patient groups

Group A (Ferrous sulphate)

Active Comparator group

Description:

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.

Treatment:

Drug: Ferrous sulfate

Group B (Iron Polymaltose complex)

Active Comparator group

Description:

Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.

Treatment:

Drug: Iron Polymaltose Complex