Vitamin D InsufficiencyNCT00273611
Vitamin D Levels and Vitamin D Education in Geriatric Patients
A study testing Pharmacist Education about Vitamin D in people with Vitamin D Insufficiency and Vitamin D Deficiency, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Vitamin D is important to maintain good health. Although it is found in foods and vitamins, many people still have low vitamin D levels. One purpose of this study is to describe vitamin D levels from patients at the University of Colorado Seniors Clinic. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Vitamin D Insufficiency, Vitamin D Deficiency
- What is being tested?
- Pharmacist Education about Vitamin D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to May 2006
- 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 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient at the University of Colorado Hospital Seniors Clinic with an appointment in December 2005 or January 2006
- Age 65-89 years
Who cannot join
- History of dementia or memory loss
- Severe illness or life expectancy less than 6 months
- Assistance with medications from an assisted living facility
- History of celiac Sprue, Crohn's disease, or chronic pancreatitis
- High calcium levels, high parathyroid hormone levels, low phosphorus levels, or very high vitamin D levels
- Taking prescription vitamin D
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital Seniors Clinic
Aurora, Colorado, 80045
About this study
Official title: Characterization of Vitamin D Levels and Affect of Pharmacist-initiated Vitamin D Education in Geriatric Outpatients.
Vitamin D is important to maintain good health. Although it is found in foods and vitamins, many people still have low vitamin D levels. One purpose of this study is to describe vitamin D levels from patients at the University of Colorado Seniors Clinic. Another goal of the study is to find out if education by a pharmacist can increase vitamin D levels in patients who have low vitamin D levels.
- Conditions
- Vitamin D Insufficiency, Vitamin D Deficiency
- Being tested
- Pharmacist Education about Vitamin D
- Keywords
- vitamin D deficiency, geriatric patients
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Education about Vitamin DBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist education | Experimental | Pharmacist education about vitamin D Receives: Behavioral: Pharmacist Education about Vitamin D |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH) vitamin D level
Change in vitamin D level after usual care or pharmacist education
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Sunny Linnebur, Pharm.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273611
- Sponsor's protocol ID
- 05-0799
- Other IDs
- 5M01RR000051
- Status last verified
- Nov 2013
- First submitted
- 4 Jan 2006
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vande Griend JP, Linnebur SA, Ruscin JM, Vondracek SF, Wolfe P, McDermott MT. Vitamin D intervention by pharmacists in geriatric outpatients. J Am Pharm Assoc (2003). 2008 Jul-Aug;48(4):501-7. doi: 10.1331/JAPhA.2008.07056.
PubMed 18653426
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Vitamin D Levels and Affect of Pharmacist-initiated Vitamin D Education in Geriatric Outpatients.
- ClinicalTrials.gov ID
- NCT00273611
- Acronym / sponsor ID
- 05-0799
- Conditions
- Vitamin D Insufficiency, Vitamin D Deficiency
- Keywords
- vitamin D deficiency, geriatric patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Dec 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 9 Jan 2006 (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.
Vitamin D is important to maintain good health. Although it is found in foods and vitamins, many people still have low vitamin D levels. One purpose of this study is to describe vitamin D levels from patients at the University of Colorado Seniors Clinic. Another goal of the study is to find out if education by a pharmacist can increase vitamin D levels in patients who have low vitamin D levels.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist education | Experimental | Behavioral: Pharmacist Education about Vitamin DPharmacist education about vitamin D |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patient at the University of Colorado Hospital Seniors Clinic with an appointment in December 2005 or January 2006
- Age 65-89 years
Key exclusion criteria (6 listed)
- History of dementia or memory loss
- Severe illness or life expectancy less than 6 months
- Assistance with medications from an assisted living facility
- History of celiac Sprue, Crohn's disease, or chronic pancreatitis
- High calcium levels, high parathyroid hormone levels, low phosphorus levels, or very high vitamin D levels
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 |
|---|---|---|
| Pharmacist Education about Vitamin D | Behavioural | Pharmacist education |
Primary outcome
25(OH) vitamin D level
Time frame: 12 weeks
Change in vitamin D level after usual care or pharmacist education
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 20 Nov 2013.
- Results publication: PubMed 18653426Vande Griend JP, Linnebur SA, Ruscin JM, Vondracek SF, Wolfe P, McDermott MT. Vitamin D intervention by pharmacists in geriatric outpatients. J Am Pharm Assoc (2003). 2008 Jul-Aug;48(4):501-7. doi: 10.1331/JAPhA.2008.07056.
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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.
Sunny Linnebur, Pharm.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Education about Vitamin D in people with Vitamin D Insufficiency and Vitamin D Deficiency, run by University of Colorado, Denver at 1 site in United States.
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 20 Nov 2013. 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 United States. 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?
25(OH) vitamin D level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00273611, which also lists 1 linked publication.
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 Nov 2013.