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Official Study Title: Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Effects of Vitamin D Repletion in Patients With Parkinson's Disease
Sponsor: Emory University
Clinicaltrials.gov ID: NCT00571285
Study ID: VIDIP PILOT

Summary

Laboratory studies have suggested vitamin D could play a role in the development of PD. In addition, low vitamin D levels have been associated with slower walking speeds, worse memory and thinking, and depression.

About 150 persons who have PD and low vitamin D levels will participate in this study. Participants will be randomly (like flipping a coin) assigned to either a high dose vitamin D supplement or the Recommended Daily Allowance (RDA) for older persons. Participants will be examined in the clinic before, then three and six months after taking the vitamin D supplement. Tests of walking speed, Parkinson's rating scales, memory tests and questionnaires of mood, anxiety and fatigue will be administered.

If this study confirms that vitamin D deficiency is occurs in 80% of people with PD, other people with PD may benefit because awareness of the problem will be increased. Also, this study will help determine whether vitamin D improves overall functioning in people with PD.

Study Phase

Phase 4
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Anxiety, Balance, Cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. Moods, Depression, General PD symptoms, Loss of Energy, Memory, Walking/Gait  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms.

Time Commitment

• Six months
• 3-4 visits

Eligibility

• Minimum Age: 18
• Maximum Age: 89
• Gender(s) Accepted: Either

Inclusion Criteria

• Eligible participants must be able to provide 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. or have a legal representative (defined by Georgia Law) who can give consent.
• Diagnosis of idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD, based on history of 2/3 cardinal features of PD (tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. bradykinesia  BradykinesiaSlowness of movement. and rigidity)  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. and definite response to dopaminergic therapy.  TherapyAnother word for “treatment”.
• Vitamin D concentration measured by treating physician within previous 3 months.
• Eligible participants must be able to complete the study questionnaires and assessments (e.g., participant must be judged able to complete TUG at screening/  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. baseline)  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. .
• Participants must be free of active cancer or other serious medical condition which might reasonably preclude their completing the 6-month intervention.
• Participants must be able to complete an 8 meter walk at screening evaluation.

Exclusion Criteria

• Anyone with a history of hypercalcemia, hypercalciuria, liver failure, end-stage renal disease or kidney stones within the past 5 years will be excluded.

Enrollment

Expected Enrollment: 150 (US)
Date Enrollment Began: Jun 01 2007
Last Updated Date: Jul 08 2008
Trial Post Date: Jul 08 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00571285?term=NCT00571285&rank=1

Primary Contacts and Locations

Georgia

• Elaine Sperin, LPN — Study Coordinator
  Emory University School of Medicine
  esperin@emory.edu
  Phone: (404) 728-4786
  Department of Neurology
  1841 Clifton Rd
  Atlanta, GA 30329
  USA