The Effects of Vitamin D and Bone Loss in Parkinson's Disease

NCT ID: NCT00907972

Last Updated: 2013-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-01-31

Brief Summary

Health care burdens from neurodegenerative diseases are expected to increase disproportionately. Increasing age also predisposes this same population to other chronic diseases including osteoporosis, a progressive systemic skeletal disease characterized by low bone mass, which leads to an increase susceptibility to fractures. In the United States, 44 million people are estimated to be at risk for osteoporosis and low bone mass emphasizing the enormity of this public health problem.

Parkinson's disease is a progressive neurodegenerative disorder affecting about 1 million people. Evidence indicates that Parkinson's disease patients are at a higher risk for low bone mineral density, which can contribute to increased fractures compared to healthy subjects. In fact, several risk factors of osteoporosis in patients with PD have been identified, including advanced stages of PD, low body mass index, inadequate sunlight exposure and decreased vitamin D levels. Some or all of these factors in conjunction with decreased immobilization that may occur with PD, put patients at increased risks for fractures. Few studies however have examined bone markers in PD patients. Even fewer studies have examined the impact of Vitamin D supplementation on bone metabolism and mineralization in PD patients.

Vitamin D is an essential component in bone health, promoting calcium absorption in the gut and maintaining adequate serum calcium and phosphate concentrations, which enable normal mineralization of bone.

Detailed Description

Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease affecting approximately 1% of the population older than 50 years. There is a worldwide increase in disease prevalence due to the increasing age of human populations. The disease is characterized by tremor, stiffness of the limbs and trunk, impaired balance and coordination, and slowing of movements, leading to immobility and frequent falls. Patients also sometimes develop other symptoms, including difficulty swallowing, disturbed sleep, and emotional problems. Parkinson's disease results from the loss of dopaminergic neurons in the substantia nigra region of the brain. The cause and mechanism of continued neuron cell death in the substantia nigra is currently unknown.

Epidemiological studies suggest an association between Parkinson's disease and osteoporosis, vitamin D inadequacy and altered bone and mineral metabolism. Accumulating evidence indicates that patients with Parkinson's disease are at a higher risk for fractures compared to healthy subjects. This could be attributed to several contributing factors including increased rate of falls, vitamin D deficiency, reduced body mass index and reduced bone mineral density.

Conditions

Parkinson Disease

Study Design

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

Study Groups

Vitamin D3 supplementation

1000 IU/day of Vitamin D3

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Vitamin D3

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

Other Intervention Names

Vitamin D; Vit D; Vit D3

Eligibility Criteria

Inclusion Criteria

• Subject must be >18 yrs of age
• Subject must have a diagnosis of Parkinson's disease (Hoehn and Yahr stages I-III), confirmed by the study physician designated to complete patient staging
• Subject must sign the informed consent documentation according to MMC's IRB guidelines
• Subject must be willing and able to complete all study requirements at the designated time intervals
• Subject must agree to be randomized
• If subject has been taking a separate Vitamin D supplement other than a multivitamin within the last 6 months, the subject must be willing to discontinue Vitamin D supplement for 3 months before entering the study
• Subject must have a vitamin D level greater than 10 ng/mL
• Subjects must have a serum calcium level within the range of 8.4-10 mg/dl.
• Females subjects of child bearing potential must have a negative urine pregnancy test or have undergone a sterilization procedure

Exclusion Criteria

• Subjects < 18 years old
• Parkinson's disease patients with Hoehn and Yahr stages IV-V.
• Subjects not willing and able to complete all study requirements at the designated time intervals
• Subjects who do not agree to be randomized
• Subjects receiving treatment with bisphosphonates (more that 3 months), parathyroid hormones (PTH) or PTH derivatives, e.g. Teriparatide or Fluoride, in the last 6 months.
• Subjects with an allergy to the investigational product.
• Subjects who have a vitamin D level less than 10 ng/mL
• Subjects who do not have a serum calcium level within the range of 8.4-10 mg/dl.
• Subjects who are pregnant, verified by a urine pregnancy test*

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

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Memorial Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Plank, MD

Role: PRINCIPAL_INVESTIGATOR

Conemaugh Health System

Prema Rapuri, PhD

Role: PRINCIPAL_INVESTIGATOR

Conemaugh Health System

Locations

Conemaugh Health System - John P Murtha Neuroscience and Pain Institute

Johnstown, Pennsylvania, United States

Countries

United States

Other Identifiers

MMC 08-30

Identifier Type: -

Identifier Source: org_study_id