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Official Study Title: Effect of Vitamin D3 Supplementation in Parkinson’s Disease Patients – A Pilot Study
Sponsor: Conemaugh Health System (Memorial Medical Center) and Department of Defense
Clinicaltrials.gov ID: NCT00907972
Study ID:

Summary

Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) is the second most common neurodegenerative disorder after Alzheimer's disease affecting approximately one percent of the population older than 50 years. There is a worldwide increase in disease prevalence due to the increasing age of human populations. PD results from the loss of dopaminergic neurons in the substantia nigra  Substantia Nigra (SN)A small region in the brain stem, just above the spinal cord. Cells within the SN produce and release a chemical called dopamine, a neurotransmitter that controls movement and balance and is essential to the proper functioning of the central nervous system (CNS). region of the brain. The cause and mechanism of continued neuron cell death in the substantia nigra is currently unknown.

Epidemiological studies suggest an association between PD and osteoporosis, vitamin D inadequacy and altered bone and mineral metabolism. Accumulating evidence indicates that people with PD are at a higher risk for fractures compared to healthy persons. This could be attributed to several contributing factors including increased rate of falls, vitamin D deficiency, reduced body mass index and reduced bone mineral density.

This study involves the use of Vitamin D3, a vitamin that is available over the counter.  Vitamin D3 will be used for an untested reason in persons with PD.  In this study, 1000 International Units (IU) of Vitamin D3 will be given. The Food and Drug Administration  Food and Drug AdministrationThe U.S. Department of Health and Human Services is the agency responsible for ensuring the safety and effectiveness  EffectivenessAbility of a drug or treatment to produce a result. of all drugs, biologics, vaccines, and medical devices. Internet address: http://www.fda.gov. (FDA) has not approved this supplement at this dose for PD. Vitamin D3 has been approved for use in other studies to find out its safety and effectiveness in the treatment of other diseases.

The purpose of this study is to see if Vitamin D3, taken in a 1000 IU capsule for one year will effect Vitamin D blood level, bone mass, and PD symptoms. Participants will be randomized into one of two groups. (To be randomized means to be put into a group by chance.) Neither the participant nor the study staff will know which group each participant is in, and each participant has a fair and equal chance (50/50) of getting either Vitamin D3 or a placebo.  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. All participants will be asked to return for follow up at 3, 6, 9 and 12 months.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• More than six months
• There are 6 visits – 1 screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. visit, 1 baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. visit, then 3, 6, 9 and 12 months.

Eligibility

• Minimum Age: 18
• Gender(s) Accepted: Either

Inclusion Criteria

• Must be over 18 years of age
• Must have a diagnosis of Parkinson's disease
• Must sign the informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial.
• Must be willing and able to complete all study requirements at the designated time intervals
• Must agree to the possibility of having either the vitamin D or placebo
• If the person has been taking a separate Vitamin D supplement other than a multivitamin within the last 6 months, the person must be willing to discontinue Vitamin D supplement for 3 months before entering the study
• Females of child bearing potential must have a negative urine pregnancy test or have undergone a sterilization procedure
  

Exclusion Criteria

• Anyone with allergy to vitamin D
• People who are pregnant, verified by a urine pregnancy test
  

Enrollment

Expected Enrollment: 30 (US)
Date Enrollment Began: Oct 2009
Date Enrollment Ends: Oct 2011
Last Updated Date: Oct 27 2009
Trial Post Date: Oct 27 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00907972

Primary Contacts and Locations

Pennsylvania

• Lisa Pasierb, PhD
  lpasierb@conemaugh.org
  Phone: (814) 269-5248
  Conemaugh Health System - John P. Murtha Neuroscience & Pain Institute
  1450 Scalp Ave.
  Johnstown, PA 15904
  USA
  
• Monica Updyke, RN BSN CCRC
  mupdyke@conemaugh.org
  Phone: (814) 269-5201
  Conemaugh Health System - John P. Murtha Neuroscience & Pain Institute
  1450 Scalp Ave.
  Johnstown, PA 15904
  USA