Bacterial PneumoniaNCT00877422
Vitamin D Supplementation Prevents Elderly Pneumonia
A study testing Vitamin D3 in people with Bacterial Pneumonia, run by Tohoku University at 1 site in Japan.
Trial summary
Pneumonia is the fourth leading cause of death and frequently occurs in institutionalized elderly people in Japan. Recently, several clinical and experimental studies have reported the importance of vitamin D in the regulation of immune functions and its deficiency is associated with susceptibility to some infections. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bacterial Pneumonia
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2008to not given
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects are more than 65 years old and were resident in the facility for at least 6 months.
- Subjects have no conditions known to interfere with vitamin D metabolism.
Who cannot join
- Subjects are excluded if they have:
- renal failure
- hepatic failure
- hyper- or hypo-parathyroidism
- HIV infection, or malignant diseases
- Subjects are also excluded if they are taking corticosteroid, thiazide diuretics, or supplementary vitamins.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Institute of Development, Aging and Cancer, Tohoku University
1-1,Seiryo-machi,Aoba-ku,Sendai, 980-8575
About this study
Official title: Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects
Pneumonia is the fourth leading cause of death and frequently occurs in institutionalized elderly people in Japan. Recently, several clinical and experimental studies have reported the importance of vitamin D in the regulation of immune functions and its deficiency is associated with susceptibility to some infections. In the present study, the investigators hypothesize that deficiency of serum vitamin D is associated with development of pneumonia, and supplementation of vitamin D may lower the incidence of pneumonia and prolong survival in institutionalized elderly subjects.
- Conditions
- Bacterial Pneumonia
- Being tested
- Vitamin D3
- Keywords
- vitamin deficiency
- Medical subject headings
- Pneumonia, Bacterial, Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Group A and Group C are followed without drugs and Group B is followed with vitamin D3.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Group A is identified as serum vitamin D level more than 16 ng/dl. |
| Group B | Active comparator | Group B is identified as serum vitamin D level less than 16 ng/dl and is supplemented with vitamin D3. Receives: Dietary Supplement: Vitamin D3 |
| Group C | No intervention | Group C is identified as serum vitamin D less than 16 ng/dl and is not supplemented with vitamin D3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of pneumonia
Measured: one year
Secondary outcomes (1)
all cause mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial PneumoniaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tohoku University
- Sponsor type
- University, hospital or other
- Investigators
- Hiroyuki Arai, MD, Study chair, Department of Geriatrics and Gerontology, Tohoku University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877422
- Sponsor's protocol ID
- IDAC-VD-01
- Other IDs
- KAKENHI 20390285
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects
- ClinicalTrials.gov ID
- NCT00877422
- Acronym / sponsor ID
- IDAC-VD-01
- Conditions
- Bacterial Pneumonia
- Keywords
- vitamin deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tohoku UniversityUniversity, hospital or other
- Study start
- Aug 2008
- First posted
- 7 Apr 2009 (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.
Pneumonia is the fourth leading cause of death and frequently occurs in institutionalized elderly people in Japan. Recently, several clinical and experimental studies have reported the importance of vitamin D in the regulation of immune functions and its deficiency is associated with susceptibility to some infections. In the present study, the investigators hypothesize that deficiency of serum vitamin D is associated with development of pneumonia, and supplementation of vitamin D may lower the incidence of pneumonia and prolong survival in institutionalized elderly subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Group A is identified as serum vitamin D level more than 16 ng/dl. |
| Group B | Active comparator | Dietary Supplement: Vitamin D3Group B is identified as serum vitamin D level less than 16 ng/dl and is supplemented with vitamin D3. |
| Group C | No intervention | –Group C is identified as serum vitamin D less than 16 ng/dl and is not supplemented with vitamin D3. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Subjects are more than 65 years old and were resident in the facility for at least 6 months.
- Subjects have no conditions known to interfere with vitamin D metabolism.
Key exclusion criteria (6 listed)
- Subjects are excluded if they have:
- Subjects are also excluded if they are taking corticosteroid, thiazide diuretics, or supplementary vitamins.
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 D3Group A and Group C are followed without drugs and Group B is followed with vitamin D3. | Dietary supplement | Group B |
Primary outcome
prevalence of pneumonia
Time frame: one year
1 secondary outcome
all cause mortality
Time frame: one year
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 8 Apr 2009.
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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.
Hiroyuki Arai, MD study chair
Department of Geriatrics and Gerontology, Tohoku University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Bacterial Pneumonia, run by Tohoku University at 1 site in Japan.
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 2 inclusion and 6 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 8 Apr 2009. 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 Japan. 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. 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?
prevalence of pneumonia (time frame: one year). 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 8 Apr 2009.