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

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ClinicalTrials.gov Identifier: NCT01127282
Recruitment Status : Unknown
Verified May 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 20, 2010
Last Update Posted : May 20, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
H1N1 Influenza Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) Drug: Placebo (digestive tablet) Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A: a Randomized-controlled Trial
Study Start Date : December 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin A
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vitamin
Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics
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
Placebo Comparator: Control
Placebo(digestive tablet) 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



Primary Outcome Measures :
  1. change of symptom score [ Time Frame: 1 week after initial visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127282


Contacts
Contact: Chang-Hoon Lee, MD +82- 2- 870- 2232 kauri670@gmail.com
Contact: Jong Sun Park, MD jspark.im@gmail.com

Locations
Korea, Republic of
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Chang-Hoon Lee, MD    +82- 2- 870- 2232    kauri670@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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

Responsible Party: Chang-Hoon Lee, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
ClinicalTrials.gov Identifier: NCT01127282     History of Changes
Other Study ID Numbers: Vitamin_H1N1
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: May 20, 2010
Last Verified: May 2010

Keywords provided by Seoul National University Hospital:
influenza
vitamin
improvement of symptom

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamins
Vitamin A
Retinol palmitate
Antiviral Agents
Antipyretics
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Anti-Infective Agents