Comparative study of safety and efficacy of ferric carboxymaltose and iron sucrose in wome
Phase 4
Completed
- Conditions
- Treatment of iron deficiency anemia in women with different comorbiditiesHaematological DisordersIron deficiency anaemia, unspecified
- Registration Number
- ISRCTN14484575
- Lead Sponsor
- niversity of Kashmir
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29304848
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 200
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
1. Patients with uncontrolled hypertension
2. Patients with impaired renal function
3. Patients with impaired liver function
4. Patients with heart disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured at baseline, 2 and 4 weeks:<br> 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<br> 2. Drug-related problems in patients on FCM or IS<br> 3. The time required to attain normal laboratory biomarker levels<br>
- Secondary Outcome Measures
Name Time Method Health-related quality of life (HRQOL), measured using the Medical Outcomes Study Short Form 36 (SF-36) at baseline, 2 and 4 weeks