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Efficacy of Vitamin C Injection on Fatigue in Workers After Work

This study has been completed.
Sponsor:
Collaborator:
Korean Association For Vitamin Research
Information provided by:
DongGuk University
ClinicalTrials.gov Identifier:
NCT00633581
First received: March 3, 2008
Last updated: April 8, 2009
Last verified: April 2009

March 3, 2008
April 8, 2009
March 2008
May 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Degree of fatigue at the point of time with visual analogue scale from 0 to 10 [ Time Frame: Before intravenous injection and right after completing injections ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00633581 on ClinicalTrials.gov Archive Site
  • Reactive oxygen species [ Time Frame: Before intravenous vitamin C injections, right after completing injections, and one day later ] [ Designated as safety issue: No ]
  • Plasma vitamin C level [ Time Frame: Before intravenous vitamin C injections and right after completing injections ] [ Designated as safety issue: No ]
  • Reactive oxygen species [ Time Frame: Before intravenous injections, right after completing injections, and one day later ] [ Designated as safety issue: No ]
  • Vitamin C blood level [ Time Frame: Before intravenous injections and right after completing injections ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of Vitamin C Injection on Fatigue in Workers After Work
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Fatigue
  • 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
  • Dietary Supplement: Normal saline
    Single intravenous injection of 120ml of normal saline over 30 minutes
    Other Name: normal saline
  • Experimental: 1
    Intravenous injections of 10 grams(20ml as a solution) of vitamin C with 100ml of normal saline over 30 minutes.
    Intervention: Dietary Supplement: Ascorbic acid (Vitamin C)
  • Placebo Comparator: 2
    Intravenous injections of 120ml of normal saline over 30 minutes.
    Intervention: Dietary Supplement: Normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00633581
DUIH 2008-1-1
No
ChangHwan Yeom, Kwandong University College of Medicine Myungji Hospital
DongGuk University
Korean Association For Vitamin Research
Principal Investigator: Chang H Yeom, MD, PhD KwanDong University Myungji Hospital
DongGuk University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP