Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Uremia Inflammation |
Drug: oral vitamin C |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Oral Vitamin C on The Inflammatory Biomarkers in Hemodialysis |
- the level of hsCRP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- the level of prealbumin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 128 |
| Study Start Date: | August 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
arm1, vitamin C treated first
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.
|
Drug: oral vitamin C
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. Other Name: ascorbic acid
Drug: oral vitamin C
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.
Other Name: ascorbic acid
|
| Arm 2 control first |
Drug: oral vitamin C
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. Other Name: ascorbic acid
Drug: oral vitamin C
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.
Other Name: ascorbic acid
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| China, Beijing | |
| hemodialysis center of Renal Division, Department of Medicine, Peking University First Hospital | |
| Beijing, Beijing, China, 100034 | |
| Study Director: | Li Zuo, MD | Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China |
More Information
No publications provided
| Responsible Party: | Li Zuo, Renal Division, Department of Medicine, Peking University First Hospital, Peking University First Hospital |
| ClinicalTrials.gov Identifier: | NCT01356433 History of Changes |
| Other Study ID Numbers: | d2a3scvr |
| Study First Received: | May 16, 2011 |
| Last Updated: | September 19, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Peking University First Hospital:
|
dialysis,inflammation,vitamin C |
Additional relevant MeSH terms:
|
Inflammation Uremia Pathologic Processes Kidney Diseases Urologic Diseases Ascorbic Acid Vitamins |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013