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Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease (VIDIP PILOT)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571285
First Posted: December 11, 2007
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marian L. Evatt, Emory University
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 - high dose Dietary Supplement: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Marian L. Evatt, Emory University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: June 2007
Study Completion Date: September 2015
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo capsule once a week and 600 IU vitamin D daily for 26 weeks
Dietary Supplement: Vitamin D3
600 IU Vitamin D3 capsule daily
Other Name: Cholecalciferol
Dietary Supplement: Placebo
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
Dietary Supplement: Vitamin D3
600 IU Vitamin D3 capsule daily
Other Name: Cholecalciferol
Dietary Supplement: Vitamin D3 - high dose
50,000 IU Vitamin D3 capsule once a week
Other Name: Cholecalciferol

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571285


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Marian L Evatt, MD, MSc Emory University
  More Information

Responsible Party: Marian L. Evatt, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00571285     History of Changes
Other Study ID Numbers: IRB00004539
VIDIP PILOT ( Other Identifier: Other )
First Submitted: December 7, 2007
First Posted: December 11, 2007
Last Update Posted: January 24, 2017
Last Verified: April 2016

Keywords provided by Marian L. Evatt, Emory University:
Parkinson's disease
Nutrition
Vitamin supplement
Motor function
Non-motor function

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents