Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease (VIDIP PILOT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Retrospective review of records in the Emory Movement Disorders clinic suggests vitamin D deficiency occurs in over 80% of patients with Parkinson's Disease (PD), much more frequently than in internal medicine clinics. 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. Subjects will be randomly (like flipping a coin) assigned to either high dose vitamin D supplement (54,200 IU weekly) or the Recommended Daily Allowance (RDA) for older persons (4200 IU weekly of vitamin D). Subjects will be examined in the clinic before, then 3- and 6- months after taking 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 occurs in 80% of patients, other patients may benefit because awareness of the problem will be increased. Also, this study will help determine whether vitamin D improves patients' functioning.
Currently, there is no "standard of care" for persons with low vitamin D. At the VA Medical Center, providers use a variety of supplement regimens. The Institute of Medicine (IOM) has published 600 IU per day (4200 IU per week) as the Recommended Daily Allowance (RDA). By definition, the RDA is the amount of a vitamin or supplement that will prevent 97-98% of the population from becoming deficient.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible participants must be able to provide informed consent or have a legal representative (defined by Georgia Law) who can give consent.
- Diagnosis of IPD, based on history of 2/3 cardinal features of PD (tremor, bradykinesia and rigidity) and definite response to dopaminergic therapy.
- Previous serum 25-OH 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/baseline).
- 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:
- Patients with PD, H&Y stage I-IV will be eligible to participate in this study.
- Participants must be ages 18-89 years.
- Patient with a history of hypercalcemia, hypercalciuria, liver failure, end-stage renal disease (National Kidney Foundation Classification Stage 5) or kidney stones within the past 5 years will be excluded.
- Specifically, potential participants with GFR (estimated or measured) <15 ml/min are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Placebo capsule once a week and 600 IU vitamin D daily for 26 weeks
|
600 IU Vitamin D3 capsule daily
Other Names:
Placebo capsule given once a week
|
|
Experimental: Vitamin D
50K IU vitamin D3 (high dose) weekly plus 600 IU Vitamin D3 capsule daily for 26 weeks
|
600 IU Vitamin D3 capsule daily
Other Names:
50,000 IU Vitamin D3 capsule once a week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline Visit to 3 month (Treatment Visit #1) in the TUG, timed walking task (8-meters) and UPDRS III subscore
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline Visit to 3 month (Visit #1) and 6 month (Visit #2) in the UPDRS II, BAI-II and BDI-II score.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marian L Evatt, MD, MSc, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- IRB00004539
- VIDIP PILOT (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.