Efficacy of Vitamin C Injection on Fatigue in Workers After Work

Phase 2

Completed

• Conditions: Fatigue
• Interventions: Dietary Supplement: Ascorbic acid (Vitamin C); Dietary Supplement: Normal saline

• Registration Number: NCT00633581
• Lead Sponsor: DongGuk University

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-12
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-08
• Last Update Posted: 2009-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ascorbic acid (Vitamin C)	Intravenous injections of 10 grams(20ml as a solution) of vitamin C with 100ml of normal saline over 30 minutes.
2	Normal saline	Intravenous injections of 120ml of normal saline over 30 minutes.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Reactive oxygen species	Before intravenous vitamin C injections, right after completing injections, and one day later
Plasma vitamin C level	Before intravenous vitamin C injections and right after completing injections

Trial Locations

Locations (1)

DongGuk University International Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of