Efficacy of Vitamin C Injection on Fatigue in Workers After Work

• ClinicalTrials.gov Identifier: NCT00633581
• Recruitment Status: Completed
• First Posted: March 12, 2008
• Last Update Posted: April 10, 2009
• Sponsor: DongGuk University
• Collaborator: Korean Association For Vitamin Research
• Information provided by: DongGuk University

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.

Condition or disease	Intervention/treatment	Phase
Fatigue	Dietary Supplement: Ascorbic acid (Vitamin C); Dietary Supplement: Normal saline	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• 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 Start Date: March 2008
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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; Other Names: Ascorbic acid; Merit C
Placebo Comparator: 2; 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

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Reactive oxygen species [ Time Frame: Before intravenous vitamin C injections, right after completing injections, and one day later ]
2. Plasma vitamin C level [ Time Frame: Before intravenous vitamin C injections and right after completing injections ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 49 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

Korea, Republic of

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.

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. Review.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Suh SY, Bae WK, Ahn HY, Choi SE, Jung GC, Yeom CH. Intravenous vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial. Nutr J. 2012 Jan 20;11:7. doi: 10.1186/1475-2891-11-7.

• Responsible Party: ChangHwan Yeom, Kwandong University College of Medicine Myungji Hospital
• ClinicalTrials.gov Identifier: NCT00633581
• Other Study ID Numbers: DUIH 2008-1-1
• First Posted: March 12, 2008
• Last Update Posted: April 10, 2009
• Last Verified: April 2009

Keywords provided by DongGuk University:

fatigue; ascorbic acid; oxidative stress

Additional relevant MeSH terms:

Fatigue; Ascorbic Acid; Vitamins; Micronutrients; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents