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Completed

NCT Number: NCT01356433

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

hemodialysis center of Renal Division, Department of Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Vitamin C

Drug

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 names: ascorbic acid

Primary outcomes

  1. the level of hsCRP

    Time frame: 6 months

Secondary outcomes

  1. the level of prealbumin

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Effect of Oral Vitamin C on The Inflammatory Biomarkers in Hemodialysis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 19, 2011
Registry last updated
Sep 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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