Clinical trial NCT00633581: Efficacy of Vitamin C Injection on Fatigue in Workers After Work
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fatigue
Keywords: fatigue
ascorbic acid
oxidative stress
Lead sponsor: DongGuk University
Sponsor class: OTHER
Collaborators: name: Korean Association For Vitamin Research
First posted: 2008-03-12
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Degree of fatigue at the point of time with visual analogue scale from 0 to 10
timeFrame: Before intravenous vitamin C injection and right after completing injections, and one day later
Secondary outcomes:
measure: Reactive oxygen species
timeFrame: Before intravenous vitamin C injections, right after completing injections, and one day later
measure: Plasma vitamin C level
timeFrame: Before intravenous vitamin C injections and right after completing injections
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: DongGuk University International Hospital
state: Gyeonggi-do
Study officials:
affiliation: KwanDong University Myungji Hospital
name: Chang H Yeom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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