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A study to compare liposomal iron with ferrous ascorbate in treatment of iron deficiency anaemia in childre

Phase 2
Conditions
Health Condition 1: D508- Other iron deficiency anemias
Registration Number
CTRI/2023/08/056246
Lead Sponsor
amita Mishra
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Children in the age group 6 to 59 months with Iron Deficiency Anaemia as confirmed by hematological parameters

Exclusion Criteria

1. Subjects with other causes of anemia(hemolytic anemia, bone marrow failure) as evidenced by

clinical symptoms and signs and or laboratory values

2. Subjects with ongoing blood loss

3. Subjects who have received any iron therapy or blood transfusion in the past 3 months

4. Subjects with disease interfering with iron absorption e.g. Inflammatory bowel disease, celiac

disease, bowel surgery, chronic gastrointestinal infection

5. Subjects with serious chronic medical conditions like chronic kidney disease, congenital heart disease, and chronic lung disease.

6. Subjects with prior history of allergy to iron preparations

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rise in hemoglobin levels from baseline in gram per deciliterTimepoint: 0, 4 and 12 weeks
Secondary Outcome Measures
NameTimeMethod
Adherence to medicine in both groups as measured by volume of unused drug brought in follow up visit.Timepoint: 0, 4 and 12 weeks;Change in mean corpuscular volume, corrected reticulocyte count, serum iron, serum ferritin, total iron binding capacity and transferrin saturation from baselineTimepoint: 0, 4 and 12 weeks
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