Efficacy of Vitamin C Injection on Fatigue in Workers After Work - Full Text View

Sponsors and Collaborators:	DongGuk University Korean Association For Vitamin Research
Information provided by:	DongGuk University
ClinicalTrials.gov Identifier:	NCT00633581

Purpose

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.

Condition	Intervention	Phase
Fatigue	Dietary Supplement: Ascorbic acid (Vitamin C) Dietary Supplement: Normal saline	Phase II Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Ascorbic acid

U.S. FDA Resources

Further study details as provided by DongGuk University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reactive oxygen species [ Time Frame: Before intravenous vitamin C injections, right after completing injections, and one day later ] [ Designated as safety issue: No ]
Plasma vitamin C level [ Time Frame: Before intravenous vitamin C injections and right after completing injections ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	March 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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) Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes
2: Placebo Comparator Intravenous injections of 120ml of normal saline over 30 minutes.	Dietary Supplement: Normal saline Single intravenous injection of 120ml of normal saline over 30 minutes

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

Ages Eligible for Study:	20 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633581

Locations

Korea, Republic of, Gyeonggi-do
DongGuk University International Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-773

Sponsors and Collaborators

DongGuk University

Korean Association For Vitamin Research

Investigators

Principal Investigator:

Chang H Yeom, MD, PhD

KwanDong University Myungji Hospital

More Information

Publications:

Bates DW, Schmitt W, Buchwald D, Ware NC, Lee J, Thoyer E, Kornish RJ, Komaroff AL. Prevalence of fatigue and chronic fatigue syndrome in a primary care practice. Arch Intern Med. 1993 Dec 27;153(24):2759-65.

Skapinakis P, Lewis G, Meltzer H. Clarifying the relationship between unexplained chronic fatigue and psychiatric morbidity: results from a community survey in Great Britain. Am J Psychiatry. 2000 Sep;157(9):1492-8.

Logan AC. Nutritional strategies for treating chronic fatigue syndrome. Altern Med Rev. 2001 Feb;6(1):4-6. No abstract available.

Richards RS, Roberts TK, McGregor NR, Dunstan RH, Butt HL. Blood parameters indicative of oxidative stress are associated with symptom expression in chronic fatigue syndrome. Redox Rep. 2000;5(1):35-41.

Cairns R, Hotopf M. A systematic review describing the prognosis of chronic fatigue syndrome. Occup Med (Lond). 2005 Jan;55(1):20-31. Review.

Grossi G, Perski A, Evengård B, Blomkvist V, Orth-Gomér K. Physiological correlates of burnout among women. J Psychosom Res. 2003 Oct;55(4):309-16.

Avalos I, Chung CP, Oeser A, Milne GL, Morrow JD, Gebretsadik T, Shintani A, Yu C, Stein CM. Oxidative stress in systemic lupus erythematosus: relationship to disease activity and symptoms. Lupus. 2007;16(3):195-200.

Powers SK, Hamilton K. Antioxidants and exercise. Clin Sports Med. 1999 Jul;18(3):525-36

Mantovani G, Macciò A, Madeddu C, Mura L, Massa E, Gramignano G, Lusso MR, Murgia V, Camboni P, Ferreli L. Reactive oxygen species, antioxidant mechanisms and serum cytokine levels in cancer patients: impact of an antioxidant treatment. J Cell Mol Med. 2002 Oct-Dec;6(4):570-82.

Kennedy G, Spence VA, McLaren M, Hill A, Underwood C, Belch JJ. Oxidative stress levels are raised in chronic fatigue syndrome and are associated with clinical symptoms. Free Radic Biol Med. 2005 Sep 1;39(5):584-9.

Bryer SC, Goldfarb AH. Effect of high dose vitamin C supplementation on muscle soreness, damage, function, and oxidative stress to eccentric exercise. Int J Sport Nutr Exerc Metab. 2006 Jun;16(3):270-80.

Sánchez-Moreno C, Cano MP, de Ancos B, Plaza L, Olmedilla B, Granado F, Martín A. Consumption of high-pressurized vegetable soup increases plasma vitamin C and decreases oxidative stress and inflammatory biomarkers in healthy humans. J Nutr. 2004 Nov;134(11):3021-5.

Weijl NI, Elsendoorn TJ, Lentjes EG, Hopman GD, Wipkink-Bakker A, Zwinderman AH, Cleton FJ, Osanto S. Supplementation with antioxidant micronutrients and chemotherapy-induced toxicity in cancer patients treated with cisplatin-based chemotherapy: a randomised, double-blind, placebo-controlled study. Eur J Cancer. 2004 Jul;40(11):1713-23.

Mayland CR, Bennett MI, Allan K. Vitamin C deficiency in cancer patients. Palliat Med. 2005 Jan;19(1):17-20.

Knekt P, Ritz J, Pereira MA, O'Reilly EJ, Augustsson K, Fraser GE, Goldbourt U, Heitmann BL, Hallmans G, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Rimm EB, Ascherio A. Antioxidant vitamins and coronary heart disease risk: a pooled analysis of 9 cohorts. Am J Clin Nutr. 2004 Dec;80(6):1508-20.

Responsible Party:	Kwandong University College of Medicine Myungji Hospital ( ChangHwan Yeom )
Study ID Numbers:	DUIH 2008-1-1
Study First Received:	March 3, 2008
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00633581 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by DongGuk University:

fatigue
ascorbic acid
oxidative stress

Study placed in the following topic categories:

Vitamin C
Signs and Symptoms
Antioxidants
Fatigue
Vitamins

Stress
Trace Elements
Micronutrients
Ascorbic Acid

Additional relevant MeSH terms:

Signs and Symptoms
Antioxidants
Fatigue
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions
Ascorbic Acid

ClinicalTrials.gov processed this record on September 10, 2009