Efficacy of Vitamin C Injection on Fatigue in Workers After Work
| Tracking Information | |||||
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| First Received Date ICMJE | March 3, 2008 | ||||
| Last Updated Date | April 8, 2009 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Degree of fatigue at the point of time with visual analogue scale from 0 to 10 [ Time Frame: Before intravenous injection and right after completing injections ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00633581 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Vitamin C Injection on Fatigue in Workers After Work | ||||
| Official Title ICMJE | Efficacy of High Dose Vitamin C Parenteral Supplement on Amelioration of Fatigue in Company Workers After Work: A Double-Blind, Randomized Controlled Trial | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
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| Condition ICMJE | Fatigue | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 49 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00633581 | ||||
| Other Study ID Numbers ICMJE | DUIH 2008-1-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | ChangHwan Yeom, Kwandong University College of Medicine Myungji Hospital | ||||
| Study Sponsor ICMJE | DongGuk University | ||||
| Collaborators ICMJE | Korean Association For Vitamin Research | ||||
| Investigators ICMJE |
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| Information Provided By | DongGuk University | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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