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

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, January 2008

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00593996

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)

MedlinePlus related topics: Swallowing Disorders Urinary Incontinence

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	"Evaluation of Potential Vitamin D Effects on Muscle: a Pilot Study."

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
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 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

Contacts

Contact: Diane Krueger, BS

(608) 265-6410

Locations

United States, Wisconsin
UW Osteoporosis Clinical Research Program	Recruiting
Madison, Wisconsin, United States, 53705
Principal Investigator: Neil Binkley, MD
Sub-Investigator: Sabina Agrawal, DO

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 - Institute on Aging ( Neil Binkley, MD )
Study ID Numbers:	2005-1224
Study First Received:	January 2, 2008
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00593996
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Fecal Incontinence
Otorhinolaryngologic Diseases
Esophageal disorder
Gastrointestinal Diseases
Urination Disorders
Ergocalciferols
Intestinal Diseases
Pharyngeal Diseases

Rectal Diseases
Deglutition Disorders
Signs and Symptoms
Vitamin D
Digestive System Diseases
Urologic Diseases
Urinary Incontinence
Esophageal Diseases

Additional relevant MeSH terms:

Urological Manifestations
Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009