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

NCT ID: NCT00571285

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo capsule once a week and 600 IU vitamin D daily for 26 weeks

Group Type: PLACEBO_COMPARATOR

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

600 IU Vitamin D3 capsule daily

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule given once a week

Vitamin D

50K IU vitamin D3 (high dose) weekly plus 600 IU Vitamin D3 capsule daily for 26 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

600 IU Vitamin D3 capsule daily

Vitamin D3 - high dose

Intervention Type: DIETARY_SUPPLEMENT

50,000 IU Vitamin D3 capsule once a week

Interventions

Vitamin D3

600 IU Vitamin D3 capsule daily

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 - high dose

50,000 IU Vitamin D3 capsule once a week

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsule given once a week

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Cholecalciferol; Cholecalciferol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Marian L. Evatt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marian L Evatt, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

VIDIP PILOT

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00004539

Identifier Type: -

Identifier Source: org_study_id