Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

— VIDIP PILOT  

Official title:

Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00571285
• Other study ID #: IRB00004539
• Secondary ID: VIDIP PILOT
• Status: Terminated
• Phase: Phase 4
• First received: December 7, 2007
• Last updated: January 23, 2017
• Start date: June 2007
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 2015
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Dietary Supplement:
• Vitamin D3
600 IU Vitamin D3 capsule daily
• Vitamin D3 - high dose
50,000 IU Vitamin D3 capsule once a week
• Placebo
Placebo capsule given once a week

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Visit to 3 month (Treatment Visit #1) in the TUG, timed walking task (8-meters) and UPDRS III subscore		6 months
Secondary	Change from Baseline Visit to 3 month (Visit #1) and 6 month (Visit #2) in the UPDRS II, BAI-II and BDI-II score.		6 months