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Comparative study of safety and efficacy of ferric carboxymaltose and iron sucrose in women

Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: Phase IV clinical trials

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14484575
Enrollment
200
Registered
2017-12-15
Start date
2015-07-20
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Treatment of iron deficiency anemia in women with different comorbidities Haematological Disorders Iron deficiency anaemia, unspecified

Interventions

Female patients were enrolled for the study and a well-informed written consent was taken from all the patients before starting the therapy. Participants were randomly allocated in a 1:1 ratio using S

Sponsors

University of Kashmir
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All patients diagnosed with IDA admitted/or present for consultation in the Obstetrics and Gynecology ward of SKIMS Medical College and Hospital, Bemina, Srinagar were enrolled during the study period

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled hypertension 2. Patients with impaired renal function 3. Patients with impaired liver function 4. Patients with heart disease

Design outcomes

Primary

MeasureTime frame
Measured at baseline, 2 and 4 weeks: 1. The effectiveness and safety of FCM with respect to IS in achieving the target levels of laboratory biomarkers such as Hb, mean corpuscular volume (MCV), serum iron (SI), serum ferritin (SF), transferrin saturation (TS%), total iron binding capacity (TIBC) levels as prescribed under standard guidelines 2. Drug-related problems in patients on FCM or IS 3. The time required to attain normal laboratory biomarker levels

Secondary

MeasureTime frame
Health-related quality of life (HRQOL), measured using the Medical Outcomes Study Short Form 36 (SF-36) at baseline, 2 and 4 weeks

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026