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Effect of short-term and low amount of intravenous Ascorbic Acid on reducing ferritin in Hemodialysis Patients without increasing the start dosage of erythropoietin: crossed over double blind randomized controlled trial

Protocol summary

Summary
In this study, we assessed the effect of vitamin C on elimination of the unexplained hyperferritinemia on EPO-hyporesponsive anemia in hemodialysis patients without changing the starting maintenance dosage of rEPO. In a crossed over, single blind randomized controlled trial, thirty HD patients who met the eligibility criteria, patients were randomly assigned into one of following groups. The patients in the intervention group received standard care and adjuvant therapy of 500 mg of intravenous vitamin C (IVAA) along with each dialysis session at the first week of each month (total 1500 mg/month) for three months and in the control group received standard cares only. Then, the patients passed two months wash out period and then they were crossed over for another three months. Hemoglobin, mean corpuscular volume, serum iron, iron-binding capacity, ferritin level, and TSAT were assessed every month. In addition, biointact parathyroid hormone, liver enzymes, albumin, and cholesterol were measured every 3 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904263325N3
Registration date: 2010-09-14, 1389/06/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-14, 1389/06/23
Registrant information
Name
Majgan Jalalzadeh
Name of organization / entity
Zanjan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1426 6934
Email address
jmojgan@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2009-07-23, 1388/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of short-term and low amount of intravenous Ascorbic Acid on reducing ferritin in Hemodialysis Patients without increasing the start dosage of erythropoietin: crossed over double blind randomized controlled trial
Public title
Effect of intravenous Ascorbic Acid on reducing ferritin in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: receiving hemodialysis therapy for at least 6 months, administered EPO for 6 months or longer at a dose of 80-360 U/kg/wk or greater, rolling 3-month average Hb level of 11.0 g/dL or less (110 g/L), ferritin level greater than 500 ng/Ml, transferrin saturation (TSAT) of 20% or less and administered maintenance intravenous iron (25-100 mg/week) Exclusion criteria: bone marrow malignancy, myelodysplastic syndrome, evidence of chronic infection, hemochromatosis, hemoglobinopathies, evidence of significant bleeding (decrease in Hb level ≥ 2 g/dL during the past 3 months, mean corpuscular volume greater than 100 fL, biointact parathyroid hormone (bio-PTH) level greater than 500 pg/mL (ng/L)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Faculty of Medicine, Zanjan University of Medical Sciences, Shahrake Karmandan, Zanjan, Iran
City
Zanjan
Postal code
Approval date
2010-04-14, 1389/01/25
Ethics committee reference number
19/3-3/235

Health conditions studied

1

Description of health condition studied
End-stage renal disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease

Primary outcomes

1

Description
ferritin
Timepoint
begining of each phase and after 3 months
Method of measurement
laboratory techniques

2

Description
hemoglobin
Timepoint
beginning of each phase and each months (0-1-2-3)
Method of measurement
laboratory techniques

Secondary outcomes

1

Description
Serum Iron
Timepoint
at the beginning of study and after 3 months
Method of measurement
laboratory techniques

2

Description
TIBC
Timepoint
at the beginning of study and after 3 months
Method of measurement
laboratory techniques

Intervention groups

1

Description
500mg of intravenous vitamin C (IVAA) along with each dialysis session at the first week of each month for three months (total 1500mg/3month)
Category
Treatment - Drugs

2

Description
control group did not receive any intervention
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti hemodialysis center
Full name of responsible person
Zeinolabedin Nourcheshmeh
Street address
City
Zanjan

2

Recruitment center
Name of recruitment center
Valieasr hemodialysis center
Full name of responsible person
Street address
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samsami
Street address
Zanjan University of Medical Sciences, Azadi boulevard, Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Mirzamohammadi
Position
Medical student
Other areas of specialty/work
Street address
No:8, block: 5, Zeitoon apartment, street 13, shahrake karmandan, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 1426 6934
Fax
Email
fateme_mm@yahoo.co.uk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Mirzamohammadi
Position
Medical student
Other areas of specialty/work
Street address
No:8, block: 5, Zeitoon apartment, street 13, shahrake karmandan, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 1426 6934
Fax
Email
fateme_mm@yahoo.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Mirzamohammadi
Position
Medical student
Other areas of specialty/work
Street address
No:8, block: 5, Zeitoon apartment, street 13, shahrake karmandan, Zanjan, Iran
City
Zanjan
Postal code
Phone
Fax
Email
fateme_mm@yahoo.co.uk
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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