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Efficacy of Vitamin C Injection on Fatigue in Workers After Work

Primary Purpose

Fatigue

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ascorbic acid (Vitamin C)

Normal saline

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring fatigue, ascorbic acid, oxidative stress

Eligibility Criteria

20 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

DongGuk University International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Intravenous injections of 10 grams(20ml as a solution) of vitamin C with 100ml of normal saline over 30 minutes.

Intravenous injections of 120ml of normal saline over 30 minutes.

Outcomes

Primary Outcome Measures

Degree of fatigue at the point of time with visual analogue scale from 0 to 10

Secondary Outcome Measures

Reactive oxygen species

Plasma vitamin C level

Full Information

NCT ID

NCT00633581

First Posted

March 3, 2008

Last Updated

April 8, 2009

Sponsor

DongGuk University

Collaborators

Korean Association For Vitamin Research

1. Study Identification

Unique Protocol Identification Number

NCT00633581

Brief Title

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

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

DongGuk University

Collaborators

Korean Association For Vitamin Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

fatigue, ascorbic acid, oxidative stress

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intravenous injections of 10 grams(20ml as a solution) of vitamin C with 100ml of normal saline over 30 minutes.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Intravenous injections of 120ml of normal saline over 30 minutes.

Intervention Type

Dietary Supplement

Intervention Name(s)

Ascorbic acid (Vitamin C)

Other Intervention Name(s)

Ascorbic acid, Merit C

Intervention Description

Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes

Intervention Type

Dietary Supplement

Intervention Name(s)

Normal saline

Intervention Description

Single intravenous injection of 120ml of normal saline over 30 minutes

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Reactive oxygen species

Time Frame

Before intravenous vitamin C injections, right after completing injections, and one day later

Title

Plasma vitamin C level

Time Frame

Before intravenous vitamin C injections and right after completing injections

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

49 Years

Accepts 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chang H Yeom, MD, PhD

Organizational Affiliation

KwanDong University Myungji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

DongGuk University International Hospital

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

410-773

Country

Korea, Republic of

12. IPD Sharing Statement

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Efficacy of Vitamin C Injection on Fatigue in Workers After Work

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