NCT00593996

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Last Updated

October 5, 2015

Status Verified

May 1, 2010

Enrollment Period

3.8 years

First QC Date

January 2, 2008

Last Update Submit

October 1, 2015

Conditions

DysphagiaFecal IncontinenceUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • change in lingual strength and perceived swallow function

    4 weeks

Secondary Outcomes (1)

  • change in perceived bowel and bladder function

    4 weeks

Study Arms (1)

1

PLACEBO COMPARATOR

oral placebo 3 times weekly

Other: Ergocalciferol (vitamin D2)

Interventions

Ergocalciferol (vitamin D2)OTHER

50,000 IU 3 times weekly for 4 weeks

1

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Osteoporosis Clinical Research Program

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Deglutition DisordersFecal IncontinenceUrinary Incontinence

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesRectal DiseasesIntestinal DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Neil Binkley, MD

    Univ. of Wisconsin - Institute on Aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 15, 2008

Study Start

July 1, 2006

Primary Completion

May 1, 2010

Last Updated

October 5, 2015

Record last verified: 2010-05

Locations

US(1)