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

NCT ID: NCT01356433

Last Updated: 2012-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-06-30

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.

Conditions

Uremia; Inflammation

Keywords

dialysis,inflammation,vitamin C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

oral vitamin C

Intervention Type: 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.

oral vitamin C

Intervention Type: DRUG

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.

Arm 2 control first

Group Type: OTHER

oral vitamin C

Intervention Type: 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.

oral vitamin C

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ascorbic acid; ascorbic acid

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Zuo

Renal Division, Department of Medicine, Peking University First Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Zuo, MD

Role: STUDY_DIRECTOR

Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China

Locations

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

Beijing, Beijing Municipality, China

Countries

China

References

Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

Reference Type: DERIVED

PMID: 37916745 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24228847 (View on PubMed)

Other Identifiers

d2a3scvr

Identifier Type: -

Identifier Source: org_study_id