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A clinical trial comparing the efficacy of daily dosing vs alternate day dosing of iron sulfate To evaluate the effectiveness of oral Ferrous sulfate 300 mg (60 mg elemental iron) once daily versus every other day to improve hemoglobin at 12 weeks post-initiation in iron deficiency anemia patients.

Phase 3
Conditions
Health Condition 1: D508- Other iron deficiency anemias
Registration Number
CTRI/2024/06/068631
Lead Sponsor
Aiims Raipur
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

1.Age = 16 years

2.Outpatients with iron deficiency anemia are defined as hemoglobin less than 12.0 g/dL in females or less than 13.0 g/dL in males AND ferritin less than 30 mcg/L

Exclusion Criteria

1.Pregnancy and/or currently breastfeeding

2.Known history of inflammatory bowel disease, celiac disease, thalassemia or thalassemia trait, and/or inherited bleeding disorder

3.Known intolerance or lack of response to oral ferrous gluconate, sulfate, or fumarate in the last 12 weeks

4.Multivitamin and mineral supplements (35 mg or more of elemental iron per day) in 2 weeks prior to randomization

5.Allergy to oral iron

6.Allergy to any of the following medicinal and nonmedicinal ingredients in ferrous sulfate: ferrous sulfate, calcium citrate, crospovidone, and talc titanium dioxide

7.Intravenous iron therapy in the past 12 weeks

8.On new anticoagulant therapy initiated in the past 6 months (e.g., warfarin, apixaban, dabigatran, rivaroxaban)

9.Surgery, and/or chemotherapy planned in the upcoming 12 weeks

10.Previously enrolled in the study

11.Creatinine clearance less than 30 mL/min

12.Hemoglobin less than 8.0 g/dL with active bleeding (defined as WHO grade-2 bleeding or higher in the past week

13.Recent blood donation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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