Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients
Primary Purpose
Uremia, Inflammation
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
oral vitamin C
oral vitamin C
Sponsored by

About this trial
This is an interventional treatment trial for Uremia focused on measuring dialysis,inflammation,vitamin C
Eligibility Criteria
Inclusion Criteria:
- Patients receiving maintenance hemodialysis or continuous ambulatory peritoneal dialysis, and dialysis vintage more than 3 months
- Patients aged between 18 and 80 years older
- VitC < 4ug/ml and hsCRP > 3mg/L
- for HD patients, Kt/V > 1.2 per session, at least 3 sessions per week, 4 hours per session
- for PD patients, Kt/V > 1.7 per week
- age and gender matched health control
Exclusion Criteria:
- Active autoimmune disease, malignancy, hepatitis
- Positive HIV serology
- Any kind of acute infection within one month, chronic infection
- Currently using steroids or immune-suppressants
- Pregnancy or breast feeding
Sites / Locations
- hemodialysis center of Renal Division, Department of Medicine, Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
arm1, vitamin C treated first
Arm 2 control first
Arm Description
Arm 1(50cases): intervention with oral vitamin C 200mg per day in the first 3 months, then stop oral VitC for the next 3 months.
Outcomes
Primary Outcome Measures
the level of hsCRP
Secondary Outcome Measures
the level of prealbumin
Full Information
NCT ID
NCT01356433
First Posted
May 16, 2011
Last Updated
September 19, 2012
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01356433
Brief Title
Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients
Official Title
Effect of Oral Vitamin C on The Inflammatory Biomarkers in Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subclinical inflammation is a common phenomenon in patients receiving maintenance hemodialysis (MHD). This is because various pro-inflammatory cytokines are promoted due to metabolic acidosis, volume overload, and / or non-sterile dialysate.
As important antioxidants, vitamin C was prominently consumed by oxidative stress and inflammation. So patients receiving dialysis therapy usually had a low plasma vitamin C level.
It was documented that inflammation was associated with increased risk of cardiovascular morbidity and mortality in patients on dialysis. But the relationship between plasma Vitamin C and each of inflammatory markers and prealbumin was lacking. Because vitamin C had anti-inflammation effect on behalf of its electron receiving ability, the investigators made a hypothesis that vitamin C supplementation can reduce inflammation status in patients on maintenance dialysis
Detailed Description
Objective A cross-over study is designed to elucidate if oral vitamin C supplementation can reduce inflammation status in maintenance dialysis patients with low vitamin C level and high CRP level.
Patients, Methods and Expected results Patients About 100 dialysis patients were recruited. Patients will be divided into two groups, and will be followed for at least 6 months.
Methods Arm 1(50cases): is given oral vitamin C 200mg per day in the first 3 months, then stop oral VitC for the next 3 months.
Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months.
The demographics were recorded. Plasma Vitamin C was measured by high-performance liquid chromatography. Serum albumin, prealbumin, high-sensitivity C-reactive protein (hsCRP), ferritin, hemoglobin will be measured.
Expected results There may be positive effect of vitamin C supplementation on inflammation in maintenance dialysis patients with vitamin C deficiency and high CRP level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia, Inflammation
Keywords
dialysis,inflammation,vitamin C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm1, vitamin C treated first
Arm Type
Other
Arm Description
Arm 1(50cases): intervention with oral vitamin C 200mg per day in the first 3 months, then stop oral VitC for the next 3 months.
Arm Title
Arm 2 control first
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
oral vitamin C
Other Intervention Name(s)
ascorbic acid
Intervention Description
cross-over study,2 arms Arm 1(50cases): is given oral vitamin C 200mg per day in the first 3 months, then stop oral VitC for the next 3 months.
Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months.
Intervention Type
Drug
Intervention Name(s)
oral vitamin C
Other Intervention Name(s)
ascorbic acid
Intervention Description
Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months.
Primary Outcome Measure Information:
Title
the level of hsCRP
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the level of prealbumin
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients receiving maintenance hemodialysis or continuous ambulatory peritoneal dialysis, and dialysis vintage more than 3 months
Patients aged between 18 and 80 years older
VitC < 4ug/ml and hsCRP > 3mg/L
for HD patients, Kt/V > 1.2 per session, at least 3 sessions per week, 4 hours per session
for PD patients, Kt/V > 1.7 per week
age and gender matched health control
Exclusion Criteria:
Active autoimmune disease, malignancy, hepatitis
Positive HIV serology
Any kind of acute infection within one month, chronic infection
Currently using steroids or immune-suppressants
Pregnancy or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zuo, MD
Organizational Affiliation
Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China
Official's Role
Study Director
Facility Information:
Facility Name
hemodialysis center of Renal Division, Department of Medicine, Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24228847
Citation
Zhang K, Li Y, Cheng X, Liu L, Bai W, Guo W, Wu L, Zuo L. Cross-over study of influence of oral vitamin C supplementation on inflammatory status in maintenance hemodialysis patients. BMC Nephrol. 2013 Nov 14;14:252. doi: 10.1186/1471-2369-14-252.
Results Reference
derived
Learn more about this trial
Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients
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