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

Phase 4

• Conditions: Health Condition 1: null- Anemia - Iron deficiency anemia

• Registration Number: CTRI/2011/10/002097
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 200

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 <11.5 in children(5-11 yrs), <12 in children (12-14 yrs) & non-pregnant women, <13 in adult men

5. Serum ferritin <15 µg/l

6. Obtained written informed consent

Exclusion Criteria

1. Severe anaemia ( <8gm/dl).

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified