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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: H1N1 Influenza

Treatments: Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU); Drug: Placebo (digestive tablet)

Study type: Interventional

Funder types: Other

Identifiers

NCT01127282

Vitamin_H1N1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups, including a placebo group

Vitamin

Experimental group

Description:

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

Treatment:

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

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (digestive tablet)