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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Marian L. Evatt, Emory University
ClinicalTrials.gov Identifier:
NCT00571285
First received: December 7, 2007
Last updated: January 23, 2017
Last verified: April 2016

December 7, 2007
January 23, 2017
June 2007
January 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00571285 on ClinicalTrials.gov Archive Site
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 ]
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 ]
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Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease
Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Parkinson's Disease
  • 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
  • Dietary Supplement: Placebo
    Placebo capsule given once a week
  • Placebo Comparator: Placebo
    Placebo capsule once a week and 600 IU vitamin D daily for 26 weeks
    Interventions:
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Placebo
  • Experimental: Vitamin D
    50K IU vitamin D3 (high dose) weekly plus 600 IU Vitamin D3 capsule daily for 26 weeks
    Interventions:
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Vitamin D3 - high dose
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
September 2015
January 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 89 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00571285
IRB00004539
VIDIP PILOT ( Other Identifier: Other )
No
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Marian L. Evatt, Emory University
Emory University
Not Provided
Principal Investigator: Marian L Evatt, MD, MSc Emory University
Emory University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP