Ferrous Ascorbate in the treatment of IDA
- Conditions
- Health Condition 1: E611- Iron deficiency
- Registration Number
- CTRI/2010/091/002994
- Lead Sponsor
- Zuventus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
?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 Increase in hemoglobin levelTimepoint: End of week 4, Week 8, week 12
- Secondary Outcome Measures
Name Time Method 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% <br/ ><br>while severe anemia corresponds to a level less than 7.0 gm%), <br/ ><br>2. changes in other iron <br/ ><br>indices, responder rate defined as the proportion of children becoming non-anemic [Hb more than or equal to <br/ ><br>11 gm %] and <br/ ><br>3. Incidence of any adverse events.Timepoint: 1. Week 12 <br/ ><br>2. Week 12 <br/ ><br>3. Throughout study duration.