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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease

NCT00571285

Parkinson's Disease

TERMINATED PHASE4

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

NCT00907972

Parkinson Disease

COMPLETED PHASE2

Vitamin D Supplementation and Muscle Function in Older Adults

NCT02015611

Neuromuscular Function

COMPLETED NA

Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV

NCT02031692

Benign Paroxysmal Positional Vertigo

COMPLETED PHASE4

The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population

NCT02349282

Deficiency, Vitamin D Elderly, Frail

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Accidental Falls

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

Vitamin D3 at 10,000 IU a day

calcium

Intervention Type DIETARY_SUPPLEMENT

1000mg calcium daily

Arm 2

Will be on placebo and 1000mg of calcium.

Group Type PLACEBO_COMPARATOR

calcium

Intervention Type DIETARY_SUPPLEMENT

1000mg calcium daily

Placebo

Intervention Type OTHER

A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D3

Vitamin D3 at 10,000 IU a day

Intervention Type DRUG

calcium

1000mg calcium daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No