Hypovitaminosis DNCT00204906
Correction of Vitamin D Inadequacy in Nursing Home Residents
A study testing vitamin D supplementation in people with Hypovitaminosis D, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- vitamin D supplementation
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to walk
- Reside in nursing home for the 12 weeks of study
Who cannot join
- Non-ambulatory residents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D Supplementation on Skeletal and Overall Health of Nursing Home Residents
Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy.
Read the detailed description
Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy. Subjects with low vitamin D concentrations are dosed with 50.000 IU three times a week for 25 hydroxy vitamin D, parathyroid hormone and bone turnover status. .
- Conditions
- Hypovitaminosis D
- Being tested
- vitamin D supplementation
- 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.
vitamin D supplementationDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil C Binkley, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204906
- Sponsor's protocol ID
- 2004-0057
- Status last verified
- Jun 2015
- First submitted
- 13 Sep 2005
- Last updated
- 5 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Skeletal and Overall Health of Nursing Home Residents
- ClinicalTrials.gov ID
- NCT00204906
- Acronym / sponsor ID
- 2004-0057
- Conditions
- Hypovitaminosis D
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2009 (actual)
- First posted
- 20 Sep 2005 (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 inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy.
Detailed description
Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy. Subjects with low vitamin D concentrations are dosed with 50.000 IU three times a week for 25 hydroxy vitamin D, parathyroid hormone and bone turnover status. .
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to walk
- Reside in nursing home for the 12 weeks of study
Key exclusion criteria (1 listed)
- Non-ambulatory residents
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 D supplementation | Dietary supplement | – |
Primary outcome
Not reported in the source record.
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 5 Oct 2015.
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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.
Neil C Binkley, MD principal investigator
University of Wisconsin, Madison
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 D supplementation in people with Hypovitaminosis D, run by University of Wisconsin, Madison 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 1 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 5 Oct 2015. 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.
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 5 Oct 2015.