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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00593996
First received: January 2, 2008
Last updated: May 26, 2010
Last verified: May 2010
History of Changes
  Purpose

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
Dysphagia
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593996

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

No publications provided

Responsible Party: Neil Binkley, MD, University of Wisconsin - Institute on Aging
ClinicalTrials.gov Identifier: NCT00593996     History of Changes
Other Study ID Numbers: 2005-1224
Study First Received: January 2, 2008
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Deglutition Disorders
Fecal Incontinence
Urinary Incontinence
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Rectal Diseases
Intestinal Diseases
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013