Plain English Summary
Background and study aims
Iron deficiency anaemia (IDA) is a condition where a lack of iron in the body leads to a reduction in the number of red blood cells. The aim of this study is to assess the effectiveness and safety of intravenous ferric carboxymaltose (FCM) in comparison to iron sucrose (IS) in women with IDA.
Who can participate?
Women over the age of 18 with IDA
What does the study involve?
Participants are randomly allocated to receive either FCM or IS. The study lasts for six months. Participants undergo assessments at the start of the study and at weeks 2 and 4. The goals are to find out whether it is possible to achieve target levels in laboratory tests; to identify and prevent any possible drug-related problems in patients on FCM or IS; to make suggestions for the use of these drugs whenever required by evaluating the laboratory tests; to assess the time required to attain normal laboratory tests using these two drugs; and to evaluate health-related quality of life using questionnaires.
What are the possible benefits and risks of participating?
Patients receive treatment for IDA. The study's findings should help in choosing a drug treatment for IDA in women. The main risk is an adverse drug reaction to intravenous iron.
Where is the study run from?
The study is run by the University of Kashmir and takes place in Sher-i-Kashmir Institute of Medical Sciences (SKIMS) Medical College and Hospital, Bemina, Srinagar (India)
When is the study starting and how long is it expected to run for?
May 2015 to February 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Ghulam N Bader
gnbader@kashmiruniversity.ac.in
2. Amreen Naqash
anaqash.scholar@kashmiruniversity.net
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ghulam Bader
ORCID ID
Contact details
Department of Pharmaceutical Sciences
University of Kashmir
Srinagar
190006
India
+91 (0)9419055344
gnbader@kashmiruniversity.ac.in
Type
Scientific
Additional contact
Prof Rifat Ara
ORCID ID
Contact details
Department of Obstetrics and Gynecology
SKIMS Medical College and Hospital
Srinagar
190017
India
Type
Scientific
Additional contact
Miss Amreen Naqash
ORCID ID
Contact details
Department of Pharmaceutical Sciences
University of Kashmir
Srinagar
190006
India
+91 (0)7889776179
anaqash.scholar@kashmiruniversity.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SKIMS MC/CM/IEC/15/42-50
Study information
Scientific title
Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: Phase IV clinical trials
Acronym
Study hypothesis
To check which of the two Iron preparations, ferric carboxymaltose or iron sucrose, is better in the treatment of iron deficiency anemia.
Ethics approval
Institutional Ethics Committee, Sheri-Kashmir Institute of Medical Sciences Medical College and Hospital (IEC-SKIMS MCH), 16/07/2015, ref: SKIMS MC/CM/IEC/15/42-50
Study design
Prospective longitudinal and interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Treatment of iron deficiency anemia in women with different comorbidities
Intervention
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 SNOSE to receive either ferric carboxymaltose or iron sucrose.
In conformity with the standard indicators, ferric carboxymaltose and iron sucrose was given in women with iron deficiency anemia after properly evaluating the baseline demographic and clinical characteristics of the study patients. Hospital doctors and the pharmacologist were involved in choosing a dose, maintenance of the therapy and monitoring of the adverse drug reactions (ADRs). While as the administration of the drug was done by nursing staff. According to the Ganzoni’s Formula total iron required for iron repletion was calculated at baseline. The intravenous iron infusion was given according to the iron deficit calculated by and rounded up to the nearest multiple of 100 for each individual. The maximum dose of iron sucrose was 200 mg diluted in 200 ml of sterile normal saline 0.9% and given as a slow infusion over 30 minutes. The rest of the doses, as and when required, were given on alternate days following the same procedure. The maximum single dose of FCM was 1,000 mg diluted in 250 ml of sterile normal saline 0.9% given as a slow infusion over 45 minutes. If needed, rest of the doses were given on the 8th and the 15th day. In case of any adverse drug reaction (ADR), the infusion was stopped, documented, and the patient was treated for the respective ADR.
The study lasted for six months. Participants also asked to complete HRQOL questionnaires and assessments at week 2 and 4.
Intervention type
Drug
Phase
Phase IV
Drug names
Iron sucrose, ferric carboxymaltose
Primary outcome measures
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 outcome measures
Health-related quality of life (HRQOL), measured using the Medical Outcomes Study Short Form 36 (SF-36) at baseline, 2 and 4 weeks
Overall trial start date
01/05/2015
Overall trial end date
25/02/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Mixed
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Patients with uncontrolled hypertension
2. Patients with impaired renal function
3. Patients with impaired liver function
4. Patients with heart disease
Recruitment start date
20/07/2015
Recruitment end date
13/02/2016
Locations
Countries of recruitment
India
Trial participating centre
Sher-i-Kashmir Institute of Medical Sciences Medical College and Hospital
Department of Obstetrics and Gynaecology
Bemina
Srinagar
190017
India
Sponsor information
Organisation
University of Kashmir
Sponsor details
Department of Pharmaceutical Sciences
University of Kashmir
Hazratbal
Srinagar
190006
India
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The work has been accepted for publication in BMC Women's Health.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as they contain personal information related to the patient that needs to kept confidential.
Intention to publish date
20/12/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary