Health Condition 1: E611- Iron deficiency
Conditions
Interventions
Intervention1: FERONIA-XT Suspension: Elemental Iron 3 mg/kg body weight
Control Intervention1: Tonoferon Syrup: Elemental Iron 3 mg/kg body weight
Sponsors
Zuventus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ?Children between the age group of 6 months to 12 years. ?Children having iron deficiency anemia with hemoglobin less than 10 gm%. ?Patients who would be coming for follow up after every 4 weeks for the complete study period of 12 weeks. ?Informed written consent given by parents/guardians of the patients.
Exclusion criteria
Exclusion criteria: ?Anemia due to other causes than iron deficiency anemia ?Severe concurrent illness (cardiovascular, renal, hepatic). ?Known hypersensitivity to Ferrous ascorbate or any other iron preparations ?Malignancy of any type. ?Children with thalassemia major / aplastic or hypoplastic anaemia, sickle cell anaemia, any other abnormal haemoglobinopathy or any other haemolytic anaemia. ?Any other condition that in the opinion of the investigator does not justify the patient?s inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in hemoglobin levels based on the severity of anemia at baseline (moderate anemia corresponds to a level of 7.0-9.9 gm% while severe anemia corresponds to a level less than 7.0 gm%), 2. changes in other iron indices, responder rate defined as the proportion of children becoming non-anemic [Hb more than or equal to 11 gm %] and 3. Incidence of any adverse events.Timepoint: 1. Week 12 2. Week 12 3. Throughout study duration. | — |
Primary
| Measure | Time frame |
|---|---|
| Increase in hemoglobin levelTimepoint: End of week 4, Week 8, week 12 | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd.
Outcome results
None listed