Efficacy of Vitamin C Injection on Fatigue in Workers After Work

Sponsor
DongGuk University (Other)
Overall Status
Completed
CT.gov ID
NCT00633581
Collaborator
Korean Association For Vitamin Research (Other)
150
1
2
2
74.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ascorbic acid (Vitamin C)
  • Dietary Supplement: Normal saline
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of High Dose Vitamin C Parenteral Supplement on Amelioration of Fatigue in Company Workers After Work: A Double-Blind, Randomized Controlled Trial
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Degree of fatigue at the point of time with visual analogue scale from 0 to 10 [Before intravenous vitamin C injection and right after completing injections, and one day later]

    Secondary Outcome Measures

    1. Reactive oxygen species [Before intravenous vitamin C injections, right after completing injections, and one day later]

    2. Plasma vitamin C level [Before intravenous vitamin C injections and right after completing injections]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DongGuk University International Hospital Goyang-si Gyeonggi-do Korea, Republic of 410-773

    Sponsors and Collaborators

    • DongGuk University
    • Korean Association For Vitamin Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00633581
    Other Study ID Numbers:
    • DUIH 2008-1-1
    First Posted:
    Mar 12, 2008
    Last Update Posted:
    Apr 10, 2009
    Last Verified:
    Apr 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 10, 2009