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Trial record 2 of 8 for:    Parkinson's | "vitamin d"

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

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ClinicalTrials.gov Identifier: NCT00571285
Recruitment Status : Terminated
First Posted : December 11, 2007
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Marian L. Evatt, Emory University

Tracking Information
First Submitted Date  ICMJE December 7, 2007
First Posted Date  ICMJE December 11, 2007
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE June 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00571285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease
Official Title  ICMJE Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 16, 2014)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)
150
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00571285
Other Study ID Numbers  ICMJE IRB00004539
VIDIP PILOT ( Other Identifier: Other )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marian L. Evatt, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marian L Evatt, MD, MSc Emory University
PRS Account Emory University
Verification Date April 2016

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