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

Primary Purpose

H1N1 Influenza

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)

Placebo (digestive tablet)

About this trial

This is an interventional treatment trial for H1N1 Influenza focused on measuring influenza, vitamin, improvement of symptom

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin

Control

Arm Description

Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics

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

Outcomes

Primary Outcome Measures

change of symptom score

Secondary Outcome Measures

Full Information

NCT ID

NCT01127282

First Posted

May 19, 2010

Last Updated

May 19, 2010

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01127282

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

H1N1 Influenza

Keywords

influenza, vitamin, improvement of symptom

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin

Arm Type

Experimental

Arm Description

Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)

Intervention Description

Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics

Intervention Type

Drug

Intervention Name(s)

Placebo (digestive tablet)

Intervention Description

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

Primary Outcome Measure Information:

Title

change of symptom score

Time Frame

1 week after initial visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chang-Hoon Lee, MD

Phone

+82- 2- 870- 2232

kauri670@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jong Sun Park, MD

jspark.im@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chang-Hoon Lee, MD

Organizational Affiliation

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center

City

Seoul

ZIP/Postal Code

156-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chang-Hoon Lee, MD

Phone

+82- 2- 870- 2232

kauri670@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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