Efficacy of Vitamin C Injection on Fatigue in Workers After Work

NCT ID: NCT00633581

Last Updated: 2009-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

Ascorbic acid (Vitamin C)

Intervention Type DIETARY_SUPPLEMENT

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

2

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Ascorbic acid (Vitamin C)

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

Intervention Type DIETARY_SUPPLEMENT

Normal saline

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ascorbic acid Merit C

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korean Association For Vitamin Research

UNKNOWN

Sponsor Role collaborator

DongGuk University

OTHER

Sponsor Role lead

Responsible Party

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Kwandong University College of Medicine Myungji Hospital

Principal Investigators

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Chang H Yeom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KwanDong University Myungji Hospital

Locations

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DongGuk University International Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 8257251 (View on PubMed)

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. doi: 10.1176/appi.ajp.157.9.1492.

Reference Type BACKGROUND
PMID: 10964867 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11207453 (View on PubMed)

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. doi: 10.1179/rer.2000.5.1.35.

Reference Type BACKGROUND
PMID: 10905542 (View on PubMed)

Cairns R, Hotopf M. A systematic review describing the prognosis of chronic fatigue syndrome. Occup Med (Lond). 2005 Jan;55(1):20-31. doi: 10.1093/occmed/kqi013.

Reference Type BACKGROUND
PMID: 15699087 (View on PubMed)

Grossi G, Perski A, Evengard B, Blomkvist V, Orth-Gomer K. Physiological correlates of burnout among women. J Psychosom Res. 2003 Oct;55(4):309-16. doi: 10.1016/s0022-3999(02)00633-5.

Reference Type BACKGROUND
PMID: 14507541 (View on PubMed)

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. doi: 10.1177/0961203306075802.

Reference Type BACKGROUND
PMID: 17432105 (View on PubMed)

Powers SK, Hamilton K. Antioxidants and exercise. Clin Sports Med. 1999 Jul;18(3):525-36. doi: 10.1016/s0278-5919(05)70166-6.

Reference Type BACKGROUND
PMID: 10410839 (View on PubMed)

Mantovani G, Maccio 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. doi: 10.1111/j.1582-4934.2002.tb00455.x.

Reference Type BACKGROUND
PMID: 12611641 (View on PubMed)

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. doi: 10.1016/j.freeradbiomed.2005.04.020.

Reference Type BACKGROUND
PMID: 16085177 (View on PubMed)

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. doi: 10.1123/ijsnem.16.3.270.

Reference Type BACKGROUND
PMID: 16948483 (View on PubMed)

Sanchez-Moreno C, Cano MP, de Ancos B, Plaza L, Olmedilla B, Granado F, Martin 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. doi: 10.1093/jn/134.11.3021.

Reference Type BACKGROUND
PMID: 15514269 (View on PubMed)

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. doi: 10.1016/j.ejca.2004.02.029.

Reference Type BACKGROUND
PMID: 15251161 (View on PubMed)

Mayland CR, Bennett MI, Allan K. Vitamin C deficiency in cancer patients. Palliat Med. 2005 Jan;19(1):17-20. doi: 10.1191/0269216305pm970oa.

Reference Type BACKGROUND
PMID: 15690864 (View on PubMed)

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. doi: 10.1093/ajcn/80.6.1508.

Reference Type BACKGROUND
PMID: 15585762 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22264303 (View on PubMed)

Other Identifiers

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DUIH 2008-1-1

Identifier Type: -

Identifier Source: org_study_id

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