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

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
First received: January 2, 2008
Last updated: October 1, 2015
Last verified: May 2010
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.

Condition Intervention
Fecal Incontinence
Urinary Incontinence
Other: Ergocalciferol (vitamin D2)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • change in lingual strength and perceived swallow function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in perceived bowel and bladder function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2006
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
oral placebo 3 times weekly
Other: Ergocalciferol (vitamin D2)
50,000 IU 3 times weekly for 4 weeks


Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00593996

United States, Wisconsin
UW Osteoporosis Clinical Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Neil Binkley, MD Univ. of Wisconsin - Institute on Aging
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00593996     History of Changes
Other Study ID Numbers: 2005-1224 
Study First Received: January 2, 2008
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fecal Incontinence
Urinary Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Lower Urinary Tract Symptoms
Rectal Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016