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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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H1N1 Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Vitamin

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Placebo (digestive tablet)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo (digestive tablet)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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

Principal Investigators

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Chang-Hoon Lee, MD

Role: STUDY_CHAIR

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