Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Zuo, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01356433
First received: May 16, 2011
Last updated: September 19, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • the level of hsCRP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01356433

Locations
China, Beijing
hemodialysis center of Renal Division, Department of Medicine, Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
Study Director: Li Zuo, MD Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China
  More Information

No publications provided by Peking University First Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 13, 2014