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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
  Purpose

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 Intervention Phase
Fatigue
Dietary Supplement: Ascorbic acid (Vitamin C)
Dietary Supplement: Normal saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by DongGuk University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: normal saline

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.

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633581

Locations
Korea, Republic of
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
  More Information

Publications:
Powers SK, Hamilton K. Antioxidants and exercise. Clin Sports Med. 1999 Jul;18(3):525-36

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ChangHwan Yeom, Kwandong University College of Medicine Myungji Hospital
ClinicalTrials.gov Identifier: NCT00633581     History of Changes
Other Study ID Numbers: DUIH 2008-1-1
Study First Received: March 3, 2008
Last Updated: April 8, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by DongGuk University:
fatigue
ascorbic acid
oxidative stress

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Ascorbic Acid
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014