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Effect of Vitamin C on Oxidative Stress in Patients Undergoing Continuous Ambulatory Peritoneal Dialysis

Protocol summary

Summary
This study is a prospective and randomized double-blind clinical trial. The aim of this study is effect of vitamin C on oxidative stress in patients undergoing continuous ambulatory peritoneal dialysis. Total of sample size is 40 patient with ages: 18-65 years old. The patients With peritonitis or any other infection at least four weeks before sampling, using non-steroidal and allopurinol drugs, using antioxidant drugs will be excluded. Nurse drug distributor and patients do not know about the protocol of the study and type of drug. Initially, all patients are undergoing washout for 8 weeks, it means all patients do not consume antioxidants that have already used. The patients are randomly divided into two groups by blocked randomization. After washout, First group receives 250 miligram of vitamin c and 250 miligram of vitamin B6 once in one day for 8 weeks. The second group as a control group receives placebo capsule once in one day for 8 weeks. Patients basic information such as age and sex, stature, BMI, serum triglyceride, low density lipoprotein, high density lipoprotein, total cholesterol, fasting blood sugar, hemoglobin A1c (HbA1c), albumin, uric acid, C-reactive protein, total antioxidants capacity, malonyl dialdehyde will be recorded in both groups before intervention (after washout) and after the intervention period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050227675N2
Registration date: 2017-01-20, 1395/11/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Farshid Padyab
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
padyab.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-12-25, 1395/10/05
Expected recruitment end date
2017-04-25, 1396/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin C on Oxidative Stress in Patients Undergoing Continuous Ambulatory Peritoneal Dialysis
Public title
Effect of Vitamin C on Stress in Peritoneal Dialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients treated with peritoneal dialysis for more than six months; Patients with ages: 18-65 years old; Having a regular program of CAPD, three to four times swap by two liters isotonic or hypertonic glucose solution or icodextrin solution for at least 3 months. Exclusion Criteria: The patients With peritonitis or any other infection at least four weeks before sampling; The incidence of any chronic inflammatory disease; using non-steroidal and allopurinol and antioxidant drugs; Inadequate control of diabetes or HbA1c more than 7.5 %.
Age
From 18 years old to 65 years old
Gender
Both
Phase
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.AJUMS.REC.1395.583

Health conditions studied

1

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

Primary outcomes

1

Description
Peritoneum and serum total antioxidants capacity (TAC)
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous and peritoneal sampling and sent to the laboratory

2

Description
Malonyl dialdehyde (MDA)
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous and peritoneal sampling and sent to the laboratory

Secondary outcomes

1

Description
uric acid
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

2

Description
Albumin
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

3

Description
C-reactive protein (CRP)
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

4

Description
hemoglobin A1c (HbA1c)
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

5

Description
Low density lipoprotein (LDL) and high density lipoprotein (HDL)
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

6

Description
Fasting blood sugar
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

7

Description
serum triglyceride
Timepoint
Before intervention and after completion of intervention in the eighth week
Method of measurement
Venous sampling and sent to the laboratory

Intervention groups

1

Description
Group I (intervention group): Prescription 250 miligram of vitamin c and 250 miligram of vitamin B6 once in one day for 8 weeks
Category
Treatment - Drugs

2

Description
Group II (control group): Prescription 250 mg of placebo capsule, once in one day for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Heshmat allah Shahbazian
Street address
Khomeini Hospital, ShahidAhwazian St., Ahwaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farshid Padyab
Position
Resident in internal medicine
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
s.nz1990@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shokuh Shayanpour
Position
َAssistant professor of Nephrology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Dr.shaynpour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse of Anesthesia
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
s.nz1990@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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