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Comparison of two low-dose oral iron preparations for treatment of iron deficiency anemia

Low-dose oral ferrous sulphate versus ferrous fumarate for treatment of iron deficiency anaemia: An open label randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103311
Enrollment
100
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: D50- Iron deficiency anemia

Interventions

Intervention1: Ferrous fumarate: Ferrous fumarate 200mg Once Daily Control Intervention1: Ferrous sulphate: Ferrous sulphate 200 mg Once Daily

Sponsors

JIPMER, Puducherry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed patients with iron deficiency anemia of either sex Iron deficiency anemia is defined as Hemoglobin concentration between 6-10g/dl, serum ferritin concentration of less than 30 microgram/L and peripheral blood picture consistent with iron deficiency anemia

Exclusion criteria

Exclusion criteria: Patients with iron deficiency anemia with cardiac failure Pregnant and lactating women Patient who has already been diagnosed to have iron deficiency anemia and receiving oral iron therapy Patients requiring urgent blood transfusion for anemia Patients with known allergy to ferrous sulphate or ferrous fumarate Patients known to have thalassemia Patients known to have malabsorption syndrome Patients known to have peptic ulcer disease Patients known to have coronary artery disease Patients known to have chronic kidney disease with serum creatinine of more than 2mg/dL Patients known to have liver disease Alcohol abuse with Alcohol intake of more than once per week Overt Gastrointestinal bleeding Patient who received acid suppressive therapy for more than 1 month Dimorphic or Megaloblastic picture on peripheral smear examination Patients known to have Anemia of chronic disease secondary to systemic lupus erethematousus, inflammatory bowel disease, HIV, Tuberculosis

Design outcomes

Primary

MeasureTime frame
To compare the haemoglobin increment with low-dose ferrous sulphate (once daily 200 mg tablet, with 60mg elemental iron) and ferrous fumarate (once daily 200 mg tablet with 64mg elemental iron) treatmentsTimepoint: 4 weeks

Secondary

MeasureTime frame
Assessing the adverse effects related to low-dose ferrous sulphate and ferrous fumarate treatments Assessing the treatment compliance between the two armsTimepoint: 2 weeks, 4 weeks, 8 weeks and 12 weeks;To compare the haemoglobin increment with low-dose ferrous sulphate and ferrous fumarate treatmentsTimepoint: 2 weeks, 8 weeks and 12 weeks

Countries

India

Contacts

Public ContactVinod K V

JIPMER

drkvv@rediffmail.com04132296233

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026