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

Inflammation Clinical Trial

Official title:

Effect of Oral Vitamin C on The Inflammatory Biomarkers in Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356433
• Other study ID #: d2a3scvr
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2011
• Last updated: September 19, 2012
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Uremia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	hemodialysis center of Renal Division, Department of Medicine, Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the level of hsCRP		6 months	Yes
Secondary	the level of prealbumin		6 months	Yes