DysphagiaNCT00593996
Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study
A study testing Ergocalciferol (vitamin D2) in people with Dysphagia and Fecal Incontinence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles. This study will determine if vitamin D supplementation benefits muscle functions important for swallowing, bladder and bowel function. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Fecal Incontinence, Urinary Incontinence
- What is being tested?
- Ergocalciferol (vitamin D2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2010
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients who present for evaluation to the UW Geriatric clinic including Dr. Pryzbelski's subspecialty, or Osteoporosis clinics
- Age 70 years or older
- Cognitively intact, as determined by the attending physicians at above mentioned clinics
Who cannot join
- History of, on ongoing, renal failure
- History of liver failure
- Known malabsorption
- Known disorders of parathyroid function, hyper/hypocalcemia, or other abnormalities of calcium or phosphate metabolism
- Known history of vitamin D intoxication or granulomatous disease
- active seizure disorder
- Pain associated with temporomandibular joint (TMJ)
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Osteoporosis Clinical Research Program
Madison, Wisconsin, 53705
About this study
People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles. This study will determine if vitamin D supplementation benefits muscle functions important for swallowing, bladder and bowel function.
- Conditions
- Dysphagia, Fecal Incontinence, Urinary Incontinence
- Being tested
- Ergocalciferol (vitamin D2)
- Medical subject headings
- Deglutition Disorders, Fecal Incontinence, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol (vitamin D2)Other
50,000 IU 3 times weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | oral placebo 3 times weekly Receives: Other: Ergocalciferol (vitamin D2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lingual strength and perceived swallow function
Measured: 4 weeks
Secondary outcomes (1)
change in perceived bowel and bladder function
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJul 2006
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Binkley, MD, Principal investigator, Univ. of Wisconsin - Institute on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593996
- Sponsor's protocol ID
- 2005-1224
- Status last verified
- May 2010
- First submitted
- 2 Jan 2008
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- 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
- Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study
- ClinicalTrials.gov ID
- NCT00593996
- Acronym / sponsor ID
- 2005-1224
- Conditions
- Dysphagia, Fecal Incontinence, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- May 2010 (actual)
- First posted
- 15 Jan 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.
People who do not have adequate amounts of vitamin D develop weakness of leg and arm muscles. This study will determine if vitamin D supplementation benefits muscle functions important for swallowing, bladder and bowel function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Ergocalciferol (vitamin D2)oral placebo 3 times weekly |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients who present for evaluation to the UW Geriatric clinic including Dr. Pryzbelski's subspecialty, or Osteoporosis clinics
- Age 70 years or older
- Cognitively intact, as determined by the attending physicians at above mentioned clinics
Key exclusion criteria (7 listed)
- History of, on ongoing, renal failure
- History of liver failure
- Known malabsorption
- Known disorders of parathyroid function, hyper/hypocalcemia, or other abnormalities of calcium or phosphate metabolism
- Known history of vitamin D intoxication or granulomatous 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 |
|---|---|---|
| Ergocalciferol (vitamin D2)50,000 IU 3 times weekly for 4 weeks | Other | 1 |
Primary outcome
change in lingual strength and perceived swallow function
Time frame: 4 weeks
1 secondary outcome
change in perceived bowel and bladder function
Time frame: 4 weeks
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 Binkley, MD principal investigator
Univ. of Wisconsin - Institute on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergocalciferol (vitamin D2) in people with Dysphagia and Fecal Incontinence, 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 3 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 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. 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?
change in lingual strength and perceived swallow function (time frame: 4 weeks). 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 5 Oct 2015.