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

NCT01356433 | Completed Phase 4 DMC

• 1 other identifier: d2a3scvr
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Conditions

Uremia; Inflammation

Keywords

dialysis,inflammation,vitamin C

Outcome Measures

Primary Outcomes (1)

• the level of hsCRP

  6 months

Secondary Outcomes (1)

• the level of prealbumin

  6 months

Study Arms (2)

arm1, vitamin C treated first

OTHER

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

Arm 2 control first

OTHER

Drug: oral vitamin C

Interventions

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.

Also known as: ascorbic acid

Arm 2 control first; arm1, vitamin C treated first

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (2)

• 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.

  PMID: 37916745 DERIVED

• 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.

  PMID: 24228847 DERIVED

MeSH Terms

Conditions

Uremia; Inflammation

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Li Zuo, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Renal Division, Department of Medicine, Peking University First Hospital

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 19, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

CN (1)