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Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study

Primary Purpose

Dysphagia, Fecal Incontinence, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol (vitamin D2)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • UW Osteoporosis Clinical Research Program

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

1

Arm Description

oral placebo 3 times weekly

Outcomes

Primary Outcome Measures

change in lingual strength and perceived swallow function

Secondary Outcome Measures

change in perceived bowel and bladder function

Full Information

First Posted
January 2, 2008
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00593996
Brief Title
Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study
Official Title
Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Fecal Incontinence, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
oral placebo 3 times weekly
Intervention Type
Other
Intervention Name(s)
Ergocalciferol (vitamin D2)
Intervention Description
50,000 IU 3 times weekly for 4 weeks
Primary Outcome Measure Information:
Title
change in lingual strength and perceived swallow function
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
change in perceived bowel and bladder function
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Binkley, MD
Organizational Affiliation
Univ. of Wisconsin - Institute on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Osteoporosis Clinical Research Program
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

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Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study

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