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FatiguePhase 2/3NCT00633581

Efficacy of Vitamin C Injection on Fatigue in Workers After Work

A Phase 2/3 study testing Ascorbic acid (Vitamin C) and Normal saline in people with Fatigue, run by DongGuk University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Fatigue
What is being tested?
Ascorbic acid (Vitamin C) and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteSouth Korea
Study dates
Mar 2008to May 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • DongGuk University International Hospital

    Goyang-si, Gyeonggi-do, 410-773

Other trials in South Korea

About this 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

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.

Read the 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.

Conditions
Fatigue
Being tested
Ascorbic acid (Vitamin C), Normal saline
Keywords
fatigue, ascorbic acid, oxidative stress
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ascorbic acid (Vitamin C)Dietary supplement

    Also called Ascorbic acid, Merit C

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

  • Normal salineDietary supplement

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

Study groups in NCT00633581
Study groupRoleWhat they receive
1ExperimentalIntravenous injections of 10 grams(20ml as a solution) of vitamin C with 100ml of normal saline over 30 minutes.
Receives: Dietary Supplement: Ascorbic acid (Vitamin C)
2Placebo comparatorIntravenous injections of 120ml of normal saline over 30 minutes.
Receives: Dietary Supplement: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Degree of fatigue at the point of time with visual analogue scale from 0 to 10

    Measured: Before intravenous vitamin C injection and right after completing injections, and one day later

Secondary outcomes (2)

  1. Reactive oxygen species

    Measured: Before intravenous vitamin C injections, right after completing injections, and one day later

  2. Plasma vitamin C level

    Measured: Before intravenous vitamin C injections and right after completing injections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00633581
Sponsor's protocol ID
DUIH 2008-1-1
Status last verified
Apr 2009
First submitted
3 Mar 2008
Last updated
10 Apr 2009
Results posted
No
Data monitoring committee
No

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.

    PubMed 8257251

  • 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.

    PubMed 10964867

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

    PubMed 11207453

  • 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.

    PubMed 10905542

  • 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.

    PubMed 15699087

  • 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.

    PubMed 14507541

  • 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.

    PubMed 17432105

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

    PubMed 10410839

  • 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.

    PubMed 12611641

  • 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.

    PubMed 16085177

  • 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.

    PubMed 16948483

  • 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.

    PubMed 15514269

  • 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.

    PubMed 15251161

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

    PubMed 15690864

  • 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.

    PubMed 15585762

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ascorbic acid (Vitamin C) and Normal saline in people with Fatigue, run by DongGuk University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00633581, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2009.

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