The Effects of Vitamin D and Bone Loss in Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | September 2009 |
| End Date: | May 2011 |
| Contact: | Monica Updyke, RN,BSN, CCRC |
| Email: | mupdyke@conemaugh.org |
| Phone: | (814) 269-5201 |
Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study
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.
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.
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*
We found this trial at
1
site
Johnstown, Pennsylvania 15904
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