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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin D3 - high dose; Dietary Supplement: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• 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
• Study Start Date: June 2007
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: IRB00004539; VIDIP PILOT ( Other Identifier: Other )
• 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:

Vitamin D; Cholecalciferol; Vitamins; Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ergocalciferols; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents