Effects of Vitamin D in Parkinson's Disease (PD)

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease; Accidental Falls

Treatments: Dietary Supplement: calcium; Drug: Vitamin D3; Other: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01119131

B7051-W

Details and patient eligibility

About

A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.

Full description

The proposed study is a randomized, double-blinded, placebo controlled intervention trial to measure the effects of vitamin D at (10,000IU/day) versus placebo on balance and falls in Parkinson's disease. The investigators will measure static, dynamic, and ambulatory balance, as well as strength, falls, and cognition before and after 16 weeks of therapy. Dynamic posturography will be used to measure static and ambulatory balance, a device called iMOBILITY will measure a timed up and go, and strength will be measured with the Biodex machine checking knee flexion and extension. Multiple quality of life and cognitive tests will also be performed.

Enrollment: 101 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parkinson's disease;
• ability to ambulate 50 feet;
• ability to cooperate with balance testing;
• vitamin D level less than 40ng/ml;
• balance problems;
• ability to walk 50 feet without the help of another person

Exclusion criteria

• MMSE < 25;
• another neurological or orthopedic deficit that in the examiner's opinion would affect testing;
• history of renal stones or hypercalcemia;
• unwillingness to not be on other vitamin D supplementation during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium

Treatment:

Drug: Vitamin D3

Dietary Supplement: calcium

Arm 2

Placebo Comparator group

Description:

Will be on placebo and 1000mg of calcium.

Treatment:

Other: Placebo

Dietary Supplement: calcium