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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Marian L. Evatt, Emory University
ClinicalTrials.gov Identifier:
NCT00571285
First received: December 7, 2007
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

A statement of the problem of interest 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
Drug: VITAMIN D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
subjects will take supplements containing an amount consistent with the adequate intake suggested by the IOM (600 IU daily) for vitamin D
Drug: VITAMIN D

Subjects will be randomized (1:1) to one of the following:

50K IU vitamin D weekly plus 600 IU daily (equivalent to 7743 IU daily) OR Placebo capsule once a week plus a daily MVI senior multivitamin (equivalent to 600 IU daily)


Detailed Description:
  1. A statement of the problem of interest 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.
  2. General statement of how the problem will be studied 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.
  3. How the research will advance scientific knowledge and/or human health If this study confirms that vitamin D deficiency is 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.
  4. What the standard of care, if any, is 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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571285

Contacts
Contact: Elaine Sperin, LPN 404-728-4786 esperin@emory.edu
Contact: Shirley Triche, RN, FNP striche@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Sub-Investigator: Vin Tangpricha, MD         
Sub-Investigator: Mahlon Delong, MD         
Principal Investigator: Marian L Evatt, MD, MS         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Marian L Evatt, MD, MSc Emory University
  More Information

No publications provided

Responsible Party: Marian L. Evatt, Physician, Emory University
ClinicalTrials.gov Identifier: NCT00571285     History of Changes
Other Study ID Numbers: IRB00004539, VIDIP PILOT
Study First Received: December 7, 2007
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Parkinson's disease
Nutrition
Vitamin supplement
Motor function
non-motor function

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

ClinicalTrials.gov processed this record on November 20, 2014