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

H1N1 Influenza Clinical Trial

Official title:

The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A: a Randomized-controlled Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01127282
• Other study ID #: Vitamin_H1N1
• Status: Unknown status
• Phase: Phase 4
• First received: May 19, 2010
• Last updated: May 19, 2010
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: May 2010
• Source: Seoul National University Hospital
• Contact: Chang-Hoon Lee, MD
• Phone: +82- 2- 870- 2232
• Email: kauri670[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 180
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• H1N1 Influenza
• Influenza, Human

Intervention

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 (digestive tablet)
Placebo (digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics

Locations

Country	Name	City	State
Korea, Republic of	Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of symptom score		1 week after initial visit