Trial to study the effects of two iron preparations in patients with iron deficiency anaemia (IDA)

Randomized controlled trial of evaluation of safety, efficacy and pharmacoeconomics of sodium feredetate and ferrous fumarate in the iron deficiency anemia (IDA) in a tertiary care hospital in central India

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/10/002097

Enrollment

200

Registered

2011-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Anemia - Iron deficiency anemia

Interventions

Intervention1: Combination preparation of Tablet Sodium Feredetate: drug will be used in combination as given below Sodium feredetate 700 mg equivalent to 100 mg of elemental iron Folic acid 1.5 mg

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of either gender age group 9-12 years with mild, moderate IDA 2. Adult age group >12-50 years with mild and moderate IDA 3. Serum creatinine less than 1.5 mg/dl at screening 4. Hb level 5. Serum ferritin 6. Obtained written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe anaemia ( 2. Pregnant females and Lactating mothers. 3. Patients with bleeding piles, mennorrhagia, chronic diarrhea. 4. Patient taking any interacting drug affecting iron absorption like antacids, ascorbic acids, antibiotics (tetracycline, quinolones) 5. S. Creatinine >1.5 mg/dl 6. Known hypersensitivity to any components of sodium feredetate or ferrous fumarate 7. Pregnant or sexually -active females who are of childbearing potential and who are not willing to use an acceptable form of contraception 8. Alcohol or any drug abuse within past six months 9. Any other laboratory abnormality, medical condition or psychiatric disorders which put the subjectâ??s disease management at risk or may result in the subject being unable to comply with the study.

Design outcomes

Primary

Measure	Time frame
Hb%, MCV, MCHC, MCH, RDW, Reticulocyte countTimepoint: baseline, 4 weeks, 8 weeks, 12 weeks	—

Secondary

Measure	Time frame
Serum iron, serum ferritin, TIBC, % Transferrin saturationTimepoint: baseline, 12 weeks	—

Countries

India

Contacts

Public ContactDr Rajanish kumar Sankdia

Peoples College of Medical Sciences and Research Centre, Bhopal

shinaka@rediffmail.com09752382828

Outcome results

None listed

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