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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01127282

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

change of symptom score [1 week after initial visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center	Seoul		Korea, Republic of	156-707

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