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

NCT ID: NCT00593996

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia Fecal Incontinence Urinary Incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

oral placebo 3 times weekly

Group Type PLACEBO_COMPARATOR

Ergocalciferol (vitamin D2)

Intervention Type OTHER

50,000 IU 3 times weekly for 4 weeks

Interventions

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Ergocalciferol (vitamin D2)

50,000 IU 3 times weekly for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Binkley, MD

Role: PRINCIPAL_INVESTIGATOR

Univ. of Wisconsin - Institute on Aging

Locations

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UW Osteoporosis Clinical Research Program

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2005-1224

Identifier Type: -

Identifier Source: org_study_id

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