Protocol summary

Summary
(1) Objective: The study was conducted to investigation of ascorbic acid effectiveness on Erythropoietin-hyporesponsive anemia in hemodialysis patients. (2) Design: randomized controlled trial (RCT). (3) Setting and conduct: seventy five haemodialysis patients were selected from Gorgan 5th Azar educative & therapeutic center via convenience methods. They were randomly allocated into controls (n = 25), oral ascorbic acid (POAA) group (n = 25) and intravenous ascorbic acid (IVAA) group (n = 25). (4): Participants including major eligibility criteria: Inclusion criteria were: at least 6 months history of hemodialysis, more than 6 months treatment duration with rHuEPO, serum ferritin level of 500 ng/mL or more and transferring saturation less than 20%. Exclusion criteria were: History of infection or inflammation within 3 months; C-reactive protein (CRP) level>2 mg/dL; Bleeding or hemolysis within 3 months; Folate level<4 ng/mL; Vitamin B12 level<200 pg/mL; (5) Intervention: Was administered postdialysis (three time weekly) 300mg intravenous vitamin C in IVAA group and orally 500mg vitamin C in POAA group for 8 weeks. (6) Main outcomes variables: Hemoglobin, hematocrit, serum iron, total iron binding capacity (TIBC) and serum oxalate was examined before and following therapy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306115864N3
Registration date: 2013-07-14, 1392/04/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-14, 1392/04/23
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
2012-10-22, 1391/08/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of oral and intravenous ascorbic acid effectiveness on Erythropoietin-hyporesponsive anemia in hemodialysis patients referred to Gorgan 5th Azar educative & therapeutic center
Public title
Oral and intravenous ascorbic acid effectiveness on erythropoietin-hyporesponsive anemia in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria Age between 18-70 years; At least 6 months history of hemodialysis; Having dossier in hemodialysis center; Three time hemodialysis in week and four hours for each session; duration of rHuEPO treatment ≥ 6 months; serum ferritin level of 500 ng/mL or more, transferring saturation <20%. Exclusion criteria History of infection or inflammation within 3 months; C-reactive protein (CRP) level>2 mg/dL; Bleeding or hemolysis within 3 months; Folate level<4 ng/mL; Vitamin B12 level<200 pg/mL; simultaneous participation in another study; Pregnant women.
Age
From 17 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
N/A
Randomization description
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
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
2011-05-25, 1390/03/04
Ethics committee reference number
489/35/پ گ

Health conditions studied

1

Description of health condition studied
anemia
ICD-10 code
D63.8
ICD-10 code description
Anaemia in other chronic diseases classified elsewhere

Primary outcomes

1

Description
Hemoglobin
Timepoint
Before and 8 weeks after intervention
Method of measurement
Blood examination (g/dl)

2

Description
Hematocrit
Timepoint
Before and 8 weeks after intervention
Method of measurement
Blood examination (%)

3

Description
Serum iron
Timepoint
Before and 8 weeks after intervention
Method of measurement
Blood examination (ng/ml)

4

Description
Ferritin
Timepoint
Before and 8 weeks after intervention
Method of measurement
Blood examination (ng/dl)

5

Description
Total iron binding capacity
Timepoint
Before and 8 weeks after intervention
Method of measurement
Blood examination (%)

Secondary outcomes

1

Description
Serum oxalate
Timepoint
Before and 8 weeks after intervention
Method of measurement
Blood examination mg/dl

Intervention groups

1

Description
In intravenous ascorbic acid (IVAA) group, 300mg intravenous vitamin C(three time weekly)for 8 weeks after each dialysis session
Category
Treatment - Drugs

2

Description
In oral ascorbic acid (POAA) group, 500mg vitamin C (three time weekly)for 8 weeks after each dialysis session
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gogan 5th Azar educative & therputic center
Full name of responsible person
Alireza Shariati
Street address
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 Jafar Golalipour
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
Alireza Shariati
Position
MS 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
Email
shariaty@goums.ac.ir; 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
Alireza Shariati
Position
MS 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
Email
shariaty@goums.ac.ir; 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
Alireza Shariati
Position
MS 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
Email
shariaty@goums.ac.ir; 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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