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

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

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.

Study Overview

• Status: Unknown
• Conditions: H1N1 Influenza
• Intervention / Treatment: Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU); Drug: Placebo (digestive tablet)

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chang-Hoon Lee, MD; Phone Number: +82- 2- 870- 2232; Email: kauri670@gmail.com
• Study Contact Backup: Name: Jong Sun Park, MD; Email: jspark.im@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Recruiting
    • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
    • Contact: Chang-Hoon Lee, MD; Phone Number: +82- 2- 870- 2232; Email: kauri670@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of symptom score	1 week after initial visit

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (Estimate): May 20, 2010

Study Record Updates

• Last Update Posted (Estimate): May 20, 2010
• Last Update Submitted That Met QC Criteria: May 19, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: influenza; vitamin; improvement of symptom
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: Vitamin_H1N1