H1N1 InfluenzaPhase 4NCT01127282
The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A
A Phase 4 study testing Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) in people with H1N1 Influenza, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- H1N1 Influenza
- What is being tested?
- Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years
- Acute respiratory illness suspected H1N1 infection
- Acute febrile respiratory illness(BT > 37.8) and throat pain or cough or nasal congestion
Who cannot join
- Pregnancy
- Hypersensitivity to vitamin A
- History of liver disease or renal disease
- Urinary stone disease
Trial locations and contacts
1 site in 1 country.
Jong Sun Park, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Seoul, 156-707
Chang-Hoon Lee, MD, +82- 2- 870- 2232, kauri670@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- H1N1 Influenza
- Being tested
- Vitamin (vitamin A 15 mg,C 500 mg, E 400IU), Placebo (digestive tablet)
- Keywords
- influenza, vitamin, improvement of symptom
- Medical subject headings
- Orthomyxoviridae Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)Drug
Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics
Placebo (digestive tablet)Drug
Placebo (digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics
| Study group | Role | What they receive |
|---|---|---|
| Vitamin | Experimental | Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics Receives: Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) |
| Control | Placebo comparator | Placebo(digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics Receives: Drug: Placebo (digestive tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of symptom score
Measured: 1 week after initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H1N1 InfluenzaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chang-Hoon Lee, MD, Study chair, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127282
- Sponsor's protocol ID
- Vitamin_H1N1
- Status last verified
- May 2010
- First submitted
- 19 May 2010
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT01127282
- Acronym / sponsor ID
- Vitamin_H1N1
- Conditions
- H1N1 Influenza
- Keywords
- influenza, vitamin, improvement of symptom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin | Experimental | Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics |
| Control | Placebo comparator | Drug: Placebo (digestive tablet)Placebo(digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 20 years
- Acute respiratory illness suspected H1N1 infection
- Acute febrile respiratory illness(BT > 37.8) and throat pain or cough or nasal congestion
Key exclusion criteria (4 listed)
- Pregnancy
- Hypersensitivity to vitamin A
- History of liver disease or renal disease
- Urinary stone disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Vitamin |
| Placebo (digestive tablet)Placebo (digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics | Drug | Control |
Primary outcome
change of symptom score
Time frame: 1 week after initial visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Sun Park, MD contact
Chang-Hoon Lee, MD study chair
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) in people with H1N1 Influenza, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Lee, MD (+82- 2- 870- 2232, kauri670@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of symptom score (time frame: 1 week after initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2010.