Efficacy of Vitamin C Injection on Fatigue in Workers After Work

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of High Dose Vitamin C Parenteral Supplement on Amelioration of Fatigue in Company Workers After Work: A Double-Blind, Randomized Controlled Trial

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: Ascorbic acid (Vitamin C)
* Dietary Supplement: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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)<br>* Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes<br>* Other names: Merit C;|
| Placebo Comparator: 2<br>Intravenous injections of 120ml of normal saline over 30 minutes. | Dietary Supplement: Normal saline<br>* Single intravenous injection of 120ml of normal saline over 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, ascorbic acid, oxidative stress