Protocol summary

Summary
This study was conducted to compare the effect of intravenous (Venofer) and oral iron on hemoglobin (Hb) rise in response to synthetic erythropoietin in hemodialysis patients. In this controlled single blind clinical trial, 42 hemodialysis patients with < 10 g/dl hemoglobin after seven weeks treatment with 2000 units subcutaneous erythropoietin (three times weekly at the end of each dialysis session) were selected via convenience sampling method. Also at least six mounts history of hemodialysis was necessary for including to the study. Bone marrow malignancy, evidence of chronic infection, evidence of significant bleeding (decrease in Hb level > 2g/dL during the past 3 months), hemoglobinopathies, myelodysplastic syndrome were lead to exclusion of subjects from the study. One week after the last dose of erythropoietin injection, basic measurement was done for serum levels of hemoglobin, ferrtin and iron saturation. Then patients randomly allocated into two oral and intravenous iron groups. For oral iron group patients administrated Ferrous Sulfate tablet 50 mg daily, for seven weeks and other group received 100 mg Venofer, three times weekly at the end of each dialysis sessions for seven weeks and during this time, subjects in both groups received 2000 unit subcutaneous erythropoietin (three times weekly at the end of each dialysis sessions). Finally, hemoglobin, ferrtin and iron saturation were examined following therapy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102195864N1
Registration date: 2011-08-29, 1390/06/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-08-29, 1390/06/07
Registrant information
Name
Ali Reza Shariati
Name of organization / entity
Golestan Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
shariaty@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan Medical Sciences University
Expected recruitment start date
2010-05-05, 1389/02/15
Expected recruitment end date
2010-07-06, 1389/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intravenous and Oral Iron Administration on Responsiveness to Synthetic Erythropoietin in Hemoglobin Increase of Hemodialysis Patients
Public title
The Treatment of Hemodialysis Patients' Anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Receiving hemodialysis therapy for at least 6 months; having dossier in hemodialysis ceneter; three time hemodialysis weekly and four hours for each session; hemoglobin less than 10 g/dl; history of seven weeks treatment with subcutaneous erythropoietin (2000 units, three times weekly at the end of each dialysis sessions). Exclusion criteria: Bone marrow malignancy; evidence of chronic infection; evidence of significant bleeding (decrease in Hb level > 2g/dL during the past 3 months); hemoglobinopathies; myelodysplastic syndrome.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Golestan Medical Sciences University
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th km of Gorgan to Sari Road, Gorgan
City
Gorgan
Postal code
Approval date
2011-01-30, 1389/11/10
Ethics committee reference number
2906/ 35/پگ

Health conditions studied

1

Description of health condition studied
Iron Deficiency Anaemia
ICD-10 code
D50.8, D50
ICD-10 code description
Other iron deficiency anaemias, Iron deficiency anaemia, unspecified

Primary outcomes

1

Description
Hemoglobin
Timepoint
Pre and Post of Intervention
Method of measurement
Blood Exam

2

Description
Ferrtin
Timepoint
Pre and Post of Intervention
Method of measurement
Blood Exam

3

Description
Total Iron Bonding Capasity
Timepoint
Pre and Post of Intervention
Method of measurement
Blood Exam

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 100 mg intravenous Venofer, three times weekly at the end of each dialysis sessions for seven weeks
Category
Treatment - Drugs

2

Description
Control group: Ferrous Sulfate tablet 50 mg daily, for seven weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
5th Azar Educational and Therapeutic Center
Full name of responsible person
Ali Reza Shariati
Street address
5th Azar St, Gorgan
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Golestan Medical Sciences University
Full name of responsible person
Dr Mohammad Ali Vakili
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th km of Gorgan to Sari Road, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Golestan Medical Sciences University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Golestan Medical Sciences University
Full name of responsible person
Ali Reza Shariati
Position
Master in Nursing
Other areas of specialty/work
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th km of Gorgan to Sari Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
shariati1382@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan Medical Sciences University
Full name of responsible person
Ali Reza Shariati
Position
Mastar in Nursing
Other areas of specialty/work
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th km of Gorgan to Sari Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
shariati1382@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan Medical Sciences University
Full name of responsible person
Ali Reza Shariati
Position
Master in Nursing
Other areas of specialty/work
Street address
Golestan Medical Sciences University (Falsafi Complex), Shast Kola, 5th km of Gorgan to Sari Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
+98 17 1442 5171
Email
shariati1382@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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