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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00907972
• Date of registration: 22/05/2009
• Prospective Registration: Yes
• Primary sponsor: Memorial Medical Center
• Public title: The Effects of Vitamin D and Bone Loss in Parkinson's Disease PDVD3
• Scientific title: Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study
• Date of first enrolment: September 2009
• Target sample size: 23
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00907972
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Sharon Plank, MD
• Affiliation: Conemaugh Health System

• Name: Prema Rapuri, PhD
• Affiliation: Conemaugh Health System

Key inclusion & exclusion 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*



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Dietary Supplement: Vitamin D3

Other: Placebo

Primary Outcome(s)

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) [Time Frame: 12 months]

Secondary Outcome(s)

Using the Parkinson's Quality of Life measure (PD QoL) to examine the effect of vitamin D supplementation on quality of life [Time Frame: 12 months]

Serum clacium will be measured to monitor for hypercalcemia. [Time Frame: 12 months]

Using the Unified Parkinson's Disease Rating Scale (UPDRS) to assess the impact of vitamin D supplementation on PD symptoms [Time Frame: 12 months]

Conducting a brief falls assessment to track the incidence of falls throughout the duration of the study [Time Frame: 12 months]

Secondary ID(s)

MMC 08-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Department of Defense