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Trial record 4 of 9 for:    Parkinson's | "vitamin d"

12 Weeks Vitamin D Supplementation and Physical Activity in PD Patients With DBS

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ClinicalTrials.gov Identifier: NCT04768023
Recruitment Status : Enrolling by invitation
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of Gdansk

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Parkinson Disease Drug: Juvit D3 Behavioral: steps per day Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : November 18, 2019
Actual Primary Completion Date : April 6, 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Control group
The group after 6 weeks of the research will receive placebo treatment.
Drug: Placebo
Matching amount of vegetable oil to the vitamin D3.
Other Name: Vegetable oil

Active Comparator: Control group with physical activity
The group after 6 weeks of the research will receive placebo treatment. The group will be prompt to do 3500-8000 steps per day.
Behavioral: steps per day
The participants will be prompt to do 3500-8000 steps per day.

Drug: Placebo
Matching amount of vegetable oil to the vitamin D3.
Other Name: Vegetable oil

Placebo Comparator: Placebo group
The group will receive placebo treatment for all the time of the research.
Drug: Placebo
Matching amount of vegetable oil to the vitamin D3.
Other Name: Vegetable oil

Placebo Comparator: Placebo group with physical activity
The group will receive placebo treatment for all the time of the research. The group will be prompt to do 3500-8000 steps per day.
Behavioral: steps per day
The participants will be prompt to do 3500-8000 steps per day.

Drug: Placebo
Matching amount of vegetable oil to the vitamin D3.
Other Name: Vegetable oil

Experimental: Vitamin D3 group
The group will receive vitamin D3 supplementation.
Drug: 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.
Other Name: vitamin D3

Experimental: Vitamin D3 group with physical activity
The group will receive vitamin D3 supplementation. The group will be prompt to do 3500-8000 steps per day.
Drug: 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.
Other Name: vitamin D3

Behavioral: steps per day
The participants will be prompt to do 3500-8000 steps per day.




Primary Outcome Measures :
  1. 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 [ Time Frame: The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood. ]
    The blood will be collected two times - before the start of supplementation and physical activity and after 12 weeks of supplementation and physical activity - then the serum samples will be stored in -80oC before the analysis. Changes in concentration of vitamin D3 will be assessed by using liquid chromatography coupled with tandem mass spectrometry technique (LC-MS/MS).

  2. 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 [ Time Frame: The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood. ]
    The blood will be collected two times - before the start of the supplementation and physical activity and after 12 weeks of supplementation and physical activity - then the serum samples will be stored in -80oC before the analysis. Changes in the concentration of IL-2, IL-6, IL-15, and TNF-α will be assessed by using a commercially available enzyme-linked immunosorbent assay (ELISA) kits.

  3. 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 [ Time Frame: The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood. ]
    The blood will be collected two times - before the start of the supplementation and physical activity and after 12 weeks of supplementation and physical activity - then the serum samples will be stored in -80oC before the analysis. Changes in the concentration of CRP will be assessed by using a commercially available enzyme-linked immunosorbent assay (ELISA) kits.

  4. 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 [ Time Frame: The outcome measure will be estimated up to 1 year after the last participant will perform the test on the last intervention. ]
    The test will be performed 3 time points. Before the supplementation and physical activity, after 6 week of supplementation and physical activity, and after 12 weeks of supplementation and physical activity. The distance covered by the participants will be measured each time and the analysis will be performed.

  5. 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 [ Time Frame: The outcome measure will be estimated up to 1 year after the last participant will perform the test on the last intervention. ]
    The Test Up & Go and 10 meter walk test will be performed 3 time points. Before the supplementation and physical activity, after 6 week of supplementation and physical activity, and after 12 weeks of supplementation and physical activity. The time achieved by the participants will be measured each time and the analysis will be performed.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768023


Locations
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Poland
Medical University of Gdansk
Gdańsk, Poland
Sponsors and Collaborators
Medical University of Gdansk
Investigators
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Principal Investigator: Zofia K Urbaś, MSc Medical University of Gdansk
Publications:

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Responsible Party: Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT04768023    
Other Study ID Numbers: PD2019/2022
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Gdansk:
parkinson's disease
deep brain stimulation
vitamin D
physical activity
functional tests
homocysteine
inflammatory markers
kynurenine pathway
Additional relevant MeSH terms:
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Parkinson Disease
Vitamin D
Vitamin D Deficiency
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents