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

September 19, 2012 updated by: Li Zuo, Peking University First Hospital

Effect of Oral Vitamin C on The Inflammatory Biomarkers in Hemodialysis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • hemodialysis center of Renal Division, Department of Medicine, Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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 Names:
  • 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 Names:
  • ascorbic acid
OTHER: 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 Names:
  • 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 Names:
  • ascorbic acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
the level of hsCRP
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
the level of prealbumin
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Li Zuo, MD, Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • d2a3scvr

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