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.

Daily versus alternate day dosing of oral Ferrous sulphate in patients of iron deficiency anemia A Randomized open label non inferiority trial - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068631

Enrollment

Registered

2024-06-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D508- Other iron deficiency anemias

Interventions

Intervention1: Ferrous Sulfate: Dose-300mg Route-Per Oral Frequency-Once Daily Duration-3months Control Intervention1: ferrous sulfate: Dose-300mg Route-Per Oral Frequency-Alternate Day Duration-3mon

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mean change in hemoglobin from baseline to end of studyTimepoint: 12weeks	—

Secondary

Measure	Time frame
Mean change in hemoglobin from baselineTimepoint: 4weeks;Proportion of patients showing an increase in hemoglobin >1.5g/dlTimepoint: 4 weeks;3. Proportion of patients with normal hemoglobin level ( >12g/dl or 13g/dl in females and males respectively)Timepoint: at the end of the study;Incidence of treatment-emergent adverse events (TEAEs)Timepoint: end of the study	—

Countries

India

Contacts

Public ContactManinder Routray

All india Institute of Medical Sciences

drpankajkannauje@aiimsraipur.edu.in9752696488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026