Efficacy of Vitamin C Injection on Fatigue in Workers After Work

April 8, 2009 updated by: DongGuk University

Efficacy of High Dose Vitamin C Parenteral Supplement on Amelioration of Fatigue in Company Workers After Work: A Double-Blind, Randomized Controlled Trial

Fatigue is one of the most frequently observed symptoms for company workers, and oxidative stress is regarded as one of its cause. Vitamin C is a well-known antioxidant, and the investigators seek for evidence of the efficacy of high dose vitamin C parenteral supplement on fatigue symptoms of company workers after work.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous studies dealing with vitamin C were focusing on terminal cancer patients or those with chronic fatigue syndrome. Since used drug dosage and the ways of administering vitamin C were not identical, the results were not consistent throughout those studies. This study is aimed to evaluate the efficacy of high dose vitamin C with parenteral supplement on relieving fatigue for apparently healthy volunteers.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

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

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-773
        • Dongguk University International 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

Ages Eligible for Study

20 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Company workers working at least 5 days a week from morning to evening
  • Volunteers who provided written informed consent

Exclusion Criteria:

  • Acute illness
  • Chronic disease such as diabetes, hypertension, liver disease, or renal disease
  • Previous history of renal stone or gout
  • Pregnant or lactating women
  • Hypersensitivity to vitamins or intravenous injections
  • History of vitamin supplements orally or parenterally within 2 days

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Intravenous injections of 10 grams(20ml as a solution) of vitamin C with 100ml of normal saline over 30 minutes.
Dietary supplement: Ascorbic acid (Vitamin C)
Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes
Other Names:
  • Ascorbic acid
  • Merit C
PLACEBO_COMPARATOR: 2
Intravenous injections of 120ml of normal saline over 30 minutes.
Dietary supplement: Normal saline
Single intravenous injection of 120ml of normal saline over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of fatigue at the point of time with visual analogue scale from 0 to 10
Time Frame: Before intravenous vitamin C injection and right after completing injections, and one day later
Before intravenous vitamin C injection and right after completing injections, and one day later

Secondary Outcome Measures

Outcome Measure
Time Frame
Reactive oxygen species
Time Frame: Before intravenous vitamin C injections, right after completing injections, and one day later
Before intravenous vitamin C injections, right after completing injections, and one day later
Plasma vitamin C level
Time Frame: Before intravenous vitamin C injections and right after completing injections
Before intravenous vitamin C injections and right after completing injections

Collaborators and Investigators

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

Sponsor

DongGuk University

Collaborators

Korean Association For Vitamin Research

Investigators

  • Principal Investigator: Chang H Yeom, MD, PhD, KwanDong University Myungji Hospital

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

March 1, 2008

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (ESTIMATE)

March 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2009

Last Update Submitted That Met QC Criteria

April 8, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUIH 2008-1-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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