Efficacy of Vitamin C Injection on Fatigue in Workers After Work

Fatigue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633581
• Other study ID #: DUIH 2008-1-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 3, 2008
• Last updated: April 8, 2009
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: April 2009
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• Ascorbic acid (Vitamin C)
Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes
• Normal saline
Single intravenous injection of 120ml of normal saline over 30 minutes

Locations

Country	Name	City	State
Korea, Republic of	DongGuk University International Hospital	Goyang-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
DongGuk University	Korean Association For Vitamin Research

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Logan AC. Nutritional strategies for treating chronic fatigue syndrome. Altern Med Rev. 2001 Feb;6(1):4-6. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reactive oxygen species		Before intravenous vitamin C injections, right after completing injections, and one day later	No
Secondary	Plasma vitamin C level		Before intravenous vitamin C injections and right after completing injections	No