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Comparison of daily oral iron treatment with alternate day treatment for correction of iron deficiency anemia

Phase 3
Completed
Conditions
Health Condition 1: D508- Other iron deficiency anemias
Registration Number
CTRI/2021/12/038370
Lead Sponsor
Jawaharlal Institute of Postgraduate Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
68
Inclusion Criteria

Newly diagnosed iron deficiency anaemia patients, with haemoglobin concentration between 6-10 g/dl, with peripheral blood smear suggestive of iron deficiency anemia and with serum ferritin level <30 mcg/l

Exclusion Criteria

1. Pregnant and lactating women

2. Already diagnosed to have iron deficiency anemia and on treatment

3. Known coronary artery disease/chronic heart failure

4. History of overt gastrointestinal bleeding (haematemesis/ melena)

5. Chronic kidney disease (serum creatinine >2 mg/dl)

6. Known malabsorption

7. Heavy alcohol abuse (alcohol intake >once/week)

8. Dimorphic anaemias

9. History of peptic ulcer disease on long term acid suppressive therapy

10. Known anaemia of chronic disease (SLE/rheumatoid arthritis/HIV infection/ Tuberculosis)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the quantum of haemoglobin increment in once daily and alternate day oral iron replacement arms on Day-28Timepoint: To assess the quantum of haemoglobin increament in once daily and alternate day oral iron replacement on Days-14 and 28
Secondary Outcome Measures
NameTimeMethod
1.To study the effect of oral iron replacement on serum hepcidin levels in the two arms at baseline and on Day-14 <br/ ><br>2.To determine frequency of adverse events and compliance with therapy in the two arms <br/ ><br>3.To assess the increment in haemoglobin concentration in the two arms on Day-56Timepoint: Day-0 (Start of intervention), Day-7,Day-14,Day-28,Day-42 and Day-56
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