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Comparative Study of Intravenous Iron versus Intravenous Ascorbic Acid for Treatment of Anaemic Hemodialysis Patients with High Ferritin and Low Transferrin Saturation

Protocol summary

Summary
This study is a single blind randomized, clinical trial that compares effect of intravenous Iron with intravenous Ascorbic Acid in treatment of functional iron deficiency in 2 hemodialysis centers. Population of study is 40 hemodialysis patients divided into two groups (20 patients in each groups). Inclusion criteria are ferritin level ≥ 500ng/ml and TSAT≤ 25%, hemodialysis therapy for ≥ 3 months, Hemoglobin level < 11 gr/dl and age≥ 18 years and<70 years. Exclusion criteria are blood transfusion or blood loss or administration of intravenous Iron during 3 months ago, acute infection, chronic inflammatory disease, active liver disease hemoglobinopathy such as sickle cell disease.The goal for response to treatment is Hb> 11 g/dl. We randomly divide 40 patients into two groups. In group I patients will receive IV infusion of 100 mg Iron sucrose, postdialysis, twice a week, during the first 5 weeks of the study. In group II 20 patients will receive 300 mg intravenous Ascorbic acid postdialysis, twice a week for 5 consecutive weeks. Fasting, predialysis blood samples will be taken to measure hemoglobin, serum iron, ferritin, total iron binding capacity (TIBC) before the start of study as baseline and at the end of study after 12 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112248501N1
Registration date: 2012-01-21, 1390/11/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-21, 1390/11/01
Registrant information
Name
Omid Sedighi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
osedighi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Intravenous Iron versus Intravenous Ascorbic Acid for Treatment of Anaemic Hemodialysis Patients with High Ferritin and Low Transferrin Saturation
Public title
Comparative Study of Intravenous Iron versus Intravenous Ascorbic Acid for Treatment of Functional Iron Deficiency in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Ferritin level ≥ 500ng/ml and TSAT≤ 25%; 2) Hemodialysis therapy for ≥ 3 months; 3) Duration of recombinant human Erythropoietin (rHYEPO) treatment ≥ 6 months at lest 6000 u/week; 4)Hemoglobin level < 11 gr/dl and Stable hemoglobin levels for four consecutive weeks; 5)The Hemodialysis patients≥ 18 years and<70 years. Exclusion criteria: 1) Blood transfusion during 3 months ago; 2) Blood loss during 3 months ago; 3) Acute infection; 4) Chronic inflammatory disease; 5) Active liver disease; 6) Hemoglobinopathy such as sickle cell disease; 7) Adminstration of intravenous Iron during 3 months ago.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Mazandaran University of Medical Sciences
Street address
Department of Research and Technology, Moallem Square
City
Sari
Postal code
Approval date
2010-09-08, 1389/06/17
Ethics committee reference number
89-70

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

2

Description of health condition studied
Iron deficiency anaemia
ICD-10 code
D50.9
ICD-10 code description
Iron deficiency anaemia, unspecified

Primary outcomes

1

Description
Hemoglobin
Timepoint
Before the drug adminstration and at the 12 weeks after the start of drug adminstration
Method of measurement
computerized coulter counter(Abbot Machine made in USA)

Secondary outcomes

1

Description
Sreum Ferritin
Timepoint
Before the drug adminstration and at the 12 weeks after the start of drug adminstration
Method of measurement
In ng/ml and will measure by LIAZON kit(made in Italy)

2

Description
Serum Iron
Timepoint
Before the drug adminstration and at the 12 weeks after the start of drug adminstration
Method of measurement
In ng/ml and will measure by Pars Azmoon kit (made in Iran) and Hitachi analyzer (Model 911, made in Japan)

3

Description
Total Iron Binding Capacity(TIBC)
Timepoint
Before the drug adminstration and at the 12 weeks after the start of drug adminstration
Method of measurement
In mg/dl and will measure by Pars Azmoon kit(made in Iran) and Hitachi analyzer (Model 911, made in Japan)

4

Description
Transferrin Saturation(TSAT)
Timepoint
Before the drug adminstration and at the 12 weeks after the start of drug adminstration
Method of measurement
In Percent and will calculate by dividing serum Iron by TIBC x 100.

Intervention groups

1

Description
Iron sucrose (Venofor st . Gallen/Switzerland) 100 mg diluted in 100 ml of Normal Saline, postdialysis, twice a week , during the first 5 weeks of the study in case group.
Category
Treatment - Drugs

2

Description
Ascorbic acid 300 mg Intravenous postdialysis, twice a week for 5 consecutive weeks in control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis Center of Imam Khomeini Hospital in Sari
Full name of responsible person
Omid Sedighi
Street address
Imam Khomeini Hospital, Amirmazandarani Blvd
City
Sari

2

Recruitment center
Name of recruitment center
Hemodialysis Center of Fatemeh Zahra Hospital in Sari
Full name of responsible person
Omid Sedighi
Street address
Artesh Bolvard
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moalem Square, Department of Research and Technology
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Omid Sedighi
Position
Nephrologist\Faculty Member
Other areas of specialty/work
Street address
Unit 3, No. 26, Peyvand 13 Alley, Peyvandi Street
City
Sari
Postal code
Phone
+98 15 1311 5225
Fax
Email
omid_sadighi2007@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Omid Sedighi
Position
Nephrologist\Faculty Member
Other areas of specialty/work
Street address
Unit 3, No. 26, Peyvand 13 Alley, Peyvandi Street
City
Sari
Postal code
Phone
+98 15 1311 5225
Fax
Email
omid_sadighi2007@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

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