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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593996
• Other study ID #: 2005-1224
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: October 1, 2015
• Start date: July 2006

Study information

• Verified date: May 2010
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphagia
• Fecal Incontinence
• Urinary Incontinence

Intervention

Other:
• Ergocalciferol (vitamin D2)
50,000 IU 3 times weekly for 4 weeks

Locations

Country	Name	City	State
United States	UW Osteoporosis Clinical Research Program	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in lingual strength and perceived swallow function		4 weeks	No
Secondary	change in perceived bowel and bladder function		4 weeks	No