The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01127282
First received: May 19, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 19, 2010
May 19, 2010
December 2009
June 2010   (final data collection date for primary outcome measure)
change of symptom score [ Time Frame: 1 week after initial visit ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A
The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A: a Randomized-controlled Trial

Influenza continues to inflict an important burden on health-care systems. The 2009 H1N1 influenza virus first appeared in Mexico and the United States in March and April 2009 and has swept the globe with unprecedented speed.

The aim of this study is to evaluate effect of supplement vitamin on the clinical course of patients with acute respiratory illness suspected novel H1N1 infection.

Patients with acute respiratory illness randomized to control or vitamin groups. The patients completed questionnaire about their initial symptom scores. After 5 days of vitamin trial, patients were asked about their symptom by telephone survey.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
H1N1 Influenza
  • Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)
    Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics
  • Drug: Placebo (digestive tablet)
    Placebo (digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics
  • Experimental: Vitamin
    Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics
    Intervention: Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)
  • Placebo Comparator: Control
    Placebo(digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics
    Intervention: Drug: Placebo (digestive tablet)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
August 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 20 years
  • Acute respiratory illness suspected H1N1 infection
  • Acute febrile respiratory illness(BT > 37.8) and throat pain or cough or nasal congestion

Exclusion Criteria:

  • Pregnancy
  • Hypersensitivity to vitamin A
  • History of liver disease or renal disease
  • Urinary stone disease
Both
18 Years and older
No
Contact: Chang-Hoon Lee, MD +82- 2- 870- 2232 kauri670@gmail.com
Contact: Jong Sun Park, MD jspark.im@gmail.com
Korea, Republic of
 
NCT01127282
Vitamin_H1N1
Yes
Chang-Hoon Lee, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Seoul National University Hospital
Not Provided
Study Chair: Chang-Hoon Lee, MD Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Seoul National University Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP