A study of two marketed formulations containing iron in anemic children.
- Conditions
- Health Condition 1: E611- Iron deficiency
- Registration Number
- CTRI/2009/091/000994
- Lead Sponsor
- Zuventus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
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.
- 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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method effect on iron indicesTimepoint: day 0 and week 12;effect on iron indicesTimepoint: day 0 and week 12
- Secondary Outcome Measures
Name Time Method adverse events reportedTimepoint: at the end of week 4, week 8 and week 12