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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593996
First Posted: January 15, 2008
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • change in perceived bowel and bladder function [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00593996     History of Changes
Other Study ID Numbers: 2005-1224
First Submitted: January 2, 2008
First Posted: January 15, 2008
Last Update Posted: October 5, 2015
Last Verified: May 2010

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