Efficacy of Vitamin C Injection on Fatigue in Workers After Work

NCT00633581 | Completed Phase 2

• 1 other identifier: DUIH 2008-1-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

fatigue; ascorbic acid; oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

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)

2

PLACEBO COMPARATOR

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

Dietary Supplement: Normal saline

Interventions

Ascorbic acid (Vitamin C) DIETARY_SUPPLEMENT

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

Also known as: Ascorbic acid, Merit C

1

Normal saline DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Company workers working at least 5 days a week from morning to evening
• Volunteers who provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• DongGuk University: lead
• Korean Association For Vitamin Research: collaborator

Study Sites (1)

DongGuk University International Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

Location

Related Publications (16)

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  PMID: 16085177 BACKGROUND

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  PMID: 16948483 BACKGROUND

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  PMID: 15514269 BACKGROUND

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  PMID: 22264303 DERIVED

MeSH Terms

Conditions

Fatigue

Interventions

Ascorbic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chang H Yeom, MD, PhD

  KwanDong University Myungji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 12, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 10, 2009

Record last verified: 2009-04

Locations

KR (1)