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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01127282
First received: May 19, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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 Intervention Phase
H1N1 Influenza
Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)
Drug: Placebo (digestive tablet)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change of symptom score [ Time Frame: 1 week after initial visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: December 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127282

Contacts
Contact: Chang-Hoon Lee, MD +82- 2- 870- 2232 kauri670@gmail.com
Contact: Jong Sun Park, MD jspark.im@gmail.com

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

No publications provided

Responsible Party: Chang-Hoon Lee, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
ClinicalTrials.gov Identifier: NCT01127282     History of Changes
Other Study ID Numbers: Vitamin_H1N1
Study First Received: May 19, 2010
Last Updated: May 19, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
influenza
vitamin
improvement of symptom

Additional relevant MeSH terms:
Vitamin A
Retinol palmitate
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antipyretics
Vitamins
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014