Clinical trial

Influence of 12 Weeks Vitamin D Supplementation Combined With Physical Activity on Blood and Functional Parameters and Quality of Life in Parkinson's Disease Patients Treated With Deep Brain Stimulation

Name

PD2019/2022

Description

Parkinson's disease (PD) is the second most frequently appearing neurodegenerative disease. It is a progressive disease of the central nervous system (CNS) and affects around 1% of people over 60 years old. During the progression decline of substantia nigra and deficits of dopamine are observed. The diagnosis is usually based on the motor symptoms such as resting tremor, bradykinesia, muscle stiffness, and postural instability. Common intercurrent symptoms are psychiatric problems like depression or dementia (1). Pharmacotherapy, for example, L-dopa or deep brain stimulation (DBS) are usually used to reduce the motor symptoms (2). From many years the influence of insufficient vitamin D3 levels in human is investigated. In recent publications it was proved that the deficiency of vitamin D3 may lead to generation of reactive oxygen species that influence negatively on mitochondria. That may lead to increased muscle atrophy (3,4). Deficiency of vitamin D3 may be also connected with depression, dementia or the progression of neurodegenerative diseases (5). Moreover, recently studies proved that PD patients have low concentration of serum vitamin D3 (5), increased serum homocysteine (6) and abnormalities in kynurenine pathway (7). It has beed proved that many forms of physical activity in PD patients improves mobility, static and dynamic balance but also may reduce the non-motor symptoms (8,9).

Trial arms

Trial start

2019-11-01

Estimated PCD

2020-04-30

Trial end

2022-02-28

Status

Completed

Treatment

Juvit D3

Dosage based on the BMI as followed: for BMI under 25 - 4000 IU/day, for BMI between 25 and 30 - 5000 IU/day, and for BMI over 30 - 6000 IU/day.

Arms:

Vitamin D3 group

Other names:

vitamin D3

Placebo

Matching amount of vegetable oil to the vitamin D3.

Arms:

Control group

Other names:

Vegetable oil

Size

Primary endpoint

The effects of vitamin D supplementation and physical activity on concentration of vitamin D3 in serum - the evaluation of changes before and after 12 weeks of supplementation and physical activity

The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood.

The effects of vitamin D supplementation and physical activity on concentration of inflammatory markers in serum - the evaluation of changes before and after 12 weeks of supplementation and physical activity

The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood.

The effects of vitamin D supplementation and physical activity on concentration of CRP in serum - the evaluation of changes before and after 12 weeks of supplementation and physical activity

The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood.

The effects of vitamin D supplementation and physical activity on the 6 minute walk test - the evaluation of changes before and after 6 and 12 weeks of supplementation and physical activity

The outcome measure will be estimated up to 1 year after the last participant will perform the test on the last intervention.

The effects of vitamin D supplementation and physical activity on the Test Up & Go and 10 meter walk test - the evaluation of changes before and after 6 weeks of supplementation and after 12 weeks of supplementation and physical activity

The outcome measure will be estimated up to 1 year after the last participant will perform the test on the last intervention.

The effects of vitamin D supplementation and physical activity on concentration of kynurenine pathway metabolites in serum - the evaluation of changes before and after 12 weeks of supplementation and physical activity

The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood.

Eligibility criteria

Inclusion Criteria: * agreement to take part in a research, * Subthalamic nucleus deep brain stimulation (STN-DBS) treatment, * willingness to work. Exclusion Criteria: * supplementation of vitamin D before the research, * serious comorbidity (like tumour, cerebrovascular disease, cardiorespiratory compromise, forced dementia).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

Updated at

2023-09-06

1 organization

1 product

1 drug

2 indications

Organization

Medical University of Gdansk

Product

Indication

Indication

Drug