Viral Upper Respiratory Tract InfectionNCT00656929
Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention
A study testing Vitamin D3 in people with Viral Upper Respiratory Tract Infection, run by Winthrop University Hospital.
Trial summary
Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Upper Respiratory Tract Infection
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 2007
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry.
Who cannot join
- morbid obesity (body mass index > 35 kg/m2)
- current tobacco use
- history of hypercalcemia, nephrolithiasis or sarcoidosis
- pregnancy
- recent hospitalization
- current liver or kidney disorders, malignancy and malabsorption
- use of immunosuppressants or medications that interfere with vitamin D metabolism such as phenytoin and carbamazepine.
About this study
Official title: A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections
Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs).
Objective: To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms in adults.
Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults. Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record the incidence and severity of URI symptoms
- Conditions
- Viral Upper Respiratory Tract Infection
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D, Viral URI, Influenza, Colds
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months
PlaceboOther
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Vitamin D3 50 mcg (2000 IU) daily Receives: Dietary Supplement: Vitamin D3 |
| 2 | Placebo comparator | Placebo tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To see whether vitamin D3 supplementation during the winter prevents viral URI.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startDec 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- John F Aloia, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656929
- Sponsor's protocol ID
- WUH06034
- Status last verified
- Apr 2008
- First submitted
- 7 Apr 2008
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT00656929
- Acronym / sponsor ID
- WUH06034
- Conditions
- Viral Upper Respiratory Tract Infection
- Keywords
- Vitamin D, Viral URI, Influenza, Colds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 11 Apr 2008 (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.
Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs).
Objective: To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms in adults.
Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults. Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record the incidence and severity of URI symptoms
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Vitamin D3Vitamin D3 50 mcg (2000 IU) daily |
| 2 | Placebo comparator | Other: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry.
Key exclusion criteria (7 listed)
- morbid obesity (body mass index > 35 kg/m2)
- current tobacco use
- history of hypercalcemia, nephrolithiasis or sarcoidosis
- pregnancy
- recent hospitalization
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 D3Also: cholecalciferolVitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months | Dietary supplement | 1 |
| PlaceboPlacebo tablets | Other | 2 |
Primary outcome
To see whether vitamin D3 supplementation during the winter prevents viral URI.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
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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.
John F Aloia, MD principal investigator
Winthrop University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Viral Upper Respiratory Tract Infection, run by Winthrop University Hospital.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To see whether vitamin D3 supplementation during the winter prevents viral URI. (time frame: 3 months). 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 11 Apr 2008.