Treatment efficacy of oral versus intravenous iron supplementation in improving the serum iron and hemoglobin status of patients with chronic kidney disease not on hemodialysis or erythropoietin
Design
Single center, parallel group, randomized controlled interventional trial
Settings and conduct
Department of Medicine, PEMH Rawalpindi
Participants divided into the intravenous iron supplementation group (Group I) (n=105) and the oral iron supplementation group (Group O) (n=105).
Participants/Inclusion and exclusion criteria
Inclusion criteria included all male and female patients over the age of 18 years not on hemodialysis or erythropoietin diagnosed as anemia with a baseline Hb of less than 13 g/dl in males and less than 12 g/dl in females with established chronic kidney disease with a GFR (glomerular filtration rate) of less than 60ml/min for more than 90 days assessed using the CKD-EPI equation and/or hyper albuminuria with urine albumin 30 mg in 24 hours or urine albumin to creatinine ratio (ACR) 30 mg/g.
Exclusion criteria included patients on dialysis, erythropoietin or use of erythropoietin stimulating agents (ESAs) in the last 3 months, patients with advanced liver, cardiac or ESKD (end-stage kidney disease), drug allergies to iron and its supplemental form during therapy or previous known history or unwilling to be included in the study.
Intervention groups
Intravenous iron group (Group I) (n=105)
Oral iron group (Group O) (n=105)
Main outcome variables
Primary variables observed were changes in the serum iron, Hb, transferrin and TIBC. Secondary variables observed were the adverse effect profile seen with both treatment regimes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231003059605N1
Registration date:2023-10-31, 1402/08/09
Registration timing:retrospective
Last update:2023-10-31, 1402/08/09
Update count:0
Registration date
2023-10-31, 1402/08/09
Registrant information
Name
Hamza Nawaz
Name of organization / entity
Armed Forces Postgraduate Medical Institute
Country
Pakistan
Phone
+92 324 5972040
Email address
hamzanawazchattha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-01-01, 1401/10/11
Actual recruitment end date
2023-06-30, 1402/04/09
Trial completion date
2023-06-30, 1402/04/09
Scientific title
COMPARISON OF ORAL VERSUS INTRAVENOUS IRON THERAPY IN IMPROVING HEMOGLOBIN STATUS IN PATIENTS OF CHRONIC KIDNEY DISEASE
Public title
ORAL VERSUS IV IRON THERAPY IN PATIENTS WITH KIDNEY DISEASE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria included all male and female patients over the age of 18 years
Not on hemodialysis or erythropoietin diagnosed as anemia with a baseline Hb of less than 13 g/dl in males and less than 12 g/dl in females
With established chronic kidney disease with a GFR (glomerular filtration rate) of less than 60ml/min for more than 90 days assessed using the CKD-EPI equation and/or hyper albuminuria with urine albumin 30 mg in 24 hours or urine albumin to creatinine ratio (ACR) 30 mg/g.
Exclusion criteria:
Exclusion criteria included patients on dialysis, erythropoietin or use of erythropoietin stimulating agents (ESAs) in the last 3 months
Patients with advanced liver, cardiac or ESKD (end-stage kidney disease)
Drug allergies to iron and its supplemental form during therapy or previous known history
Unwilling to be included in the study.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
210
Actual sample size reached:
210
Randomization (investigator's opinion)
Randomized
Randomization description
The RCT included all the assessed participants for eligibility and meeting the inclusion criteria randomized through non-probability consecutive sampling by lottery method through concealed envelopes into the intravenous iron supplementation group (Group I) (n=105) and the oral iron supplementation group (Group O) (n=105).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ERB Pak Emirates Military Hospital, Rawalpindi
Street address
Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2022-12-25, 1401/10/04
Ethics committee reference number
PEMH-RWP-003236
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
D63.1
ICD-10 code description
Anemia in chronic kidney disease
Primary outcomes
1
Description
Serum iron levels
Timepoint
4 weeks after starting therapy
Method of measurement
Blood levels
2
Description
Serum Hb
Timepoint
4 weeks after therapy
Method of measurement
Blood levels
3
Description
Serum Ferritin levels
Timepoint
4 weeks after therapy
Method of measurement
Blood levels
4
Description
Serum transferrin and TIBC levels
Timepoint
4 weeks after therapy
Method of measurement
Blood levels
Secondary outcomes
1
Description
Constipation and diarrhea
Timepoint
During 4 weeks of therapy
Method of measurement
Patient history
2
Description
Allergy to iron supplementation
Timepoint
During 4 weeks of therapy
Method of measurement
Patient assessment weekly during treatment
Intervention groups
1
Description
Intervention group: Intravenous iron supplementation group
Category
Treatment - Drugs
2
Description
Intervention group: Oral iron intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Dr Hamza Nawaz Chattha
Street address
Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 324 5972040
Email
hamzanawazchattha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hamza Nawaz Chattha
Street address
Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 324 5972040
Email
hamzanawazchattha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital Rawalpindi
Proportion provided by this source
5
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hamza Nawaz Chattha
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 324 5972040
Fax
Email
Hamzanawazchattha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hamza Nawaz Chattha
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 324 5972040
Fax
Email
Hamzanawazchattha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hamza Nawaz Chattha
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 324 5972040
Fax
Email
Hamzanawazchattha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data sets including output sheets made in SPSS 26 will be shared after permission from the author and acceptance of publication of the manuscript
When the data will become available and for how long
Data will be available indefinitely to academics after the acceptance of the manuscript for publication
To whom data/document is available
Will be available to academics after permission from the primary author
Under which criteria data/document could be used
The data will be allowed to be used for academic and research purposes
From where data/document is obtainable
Will be available online on Google drive and link would be sent after acceptance of the manuscript
What processes are involved for a request to access data/document
An official request email from the institute or academic email ID for request of data. The application would be processed within 3 days and data would be available within 2 weeks of acceptance by the primary author