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

NCT00907972 | Completed Phase 2

• 1 other identifier: MMC 08-30
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Parkinson Disease; PD; Movement Disorder

Outcome Measures

Primary Outcomes (1)

• Direct changes in bone formation and resorption will be investigated by measuring serum 25-hydroxyvitamin D [25(OH)D] level,serum parathyroid hormone (PTH) levels, serum osteocalcin, and serum n-telopeptides (N-Tx)

  12 months

Secondary Outcomes (4)

• Serum clacium will be measured to monitor for hypercalcemia.

  12 months

• Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms

  12 months

• Using the Parkinson's Quality of Life measure (PD QoL) to examine the effect of vitamin D supplementation on quality of life

  12 months

• Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study

  12 months

Study Arms (2)

Vitamin D3 supplementation

EXPERIMENTAL

1000 IU/day of Vitamin D3

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3

Also known as: Vitamin D, Vit D, Vit D3

Vitamin D3 supplementation

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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\*

Sponsors & Collaborators

• Memorial Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Conemaugh Health System - John P Murtha Neuroscience and Pain Institute

Johnstown, Pennsylvania, 15904, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sharon Plank, MD

  Conemaugh Health System

  PRINCIPAL INVESTIGATOR

• Prema Rapuri, PhD

  Conemaugh Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 12, 2013

Record last verified: 2013-07

Locations

US (1)