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

NCT04768023 | Completed

• 1 other identifier: PD2019/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Vitamin D Deficiency; Parkinson Disease

Keywords

parkinson's disease; deep brain stimulation; vitamin D; physical activity; functional tests; homocysteine; inflammatory markers; kynurenine pathway

Outcome Measures

Primary Outcomes (6)

• 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 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).

  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 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.

  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 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.

  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 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.

  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 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.

  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 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 kynurenine pathway metabolites will be assessed by using liquid chromatography coupled with tandem mass spectrometry technique (LC-MS/MS).

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

Study Arms (2)

Control group

PLACEBO COMPARATOR

The group will receive placebo treatment.

Drug: Placebo

Vitamin D3 group

EXPERIMENTAL

The group will receive vitamin D3 supplementation.

Drug: Juvit D3

Interventions

Juvit D3 DRUG

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.

Also known as: vitamin D3

Vitamin D3 group

Placebo DRUG

Matching amount of vegetable oil to the vitamin D3.

Also known as: Vegetable oil

Control group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• agreement to take part in a research,
• Subthalamic nucleus deep brain stimulation (STN-DBS) treatment,
• willingness to work.

You may not qualify if:

• supplementation of vitamin D before the research,
• serious comorbidity (like tumour, cerebrovascular disease, cardiorespiratory compromise, forced dementia).

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk

Gdansk, Poland

Location

Related Publications (9)

• da Silva AG, Leal VP, da Silva PR, Freitas FC, Linhares MN, Walz R, Malloy-Diniz LF, Diaz AP, Palha AP. Difficulties in activities of daily living are associated with stigma in patients with Parkinson's disease who are candidates for deep brain stimulation. Braz J Psychiatry. 2020 Apr;42(2):190-194. doi: 10.1590/1516-4446-2018-0333. Epub 2019 Aug 5.

  PMID: 31389495 BACKGROUND

• Aum DJ, Tierney TS. Deep brain stimulation: foundations and future trends. Front Biosci (Landmark Ed). 2018 Jan 1;23(1):162-182. doi: 10.2741/4586.

  PMID: 28930542 BACKGROUND

• Dzik KP, Kaczor JJ. Mechanisms of vitamin D on skeletal muscle function: oxidative stress, energy metabolism and anabolic state. Eur J Appl Physiol. 2019 Apr;119(4):825-839. doi: 10.1007/s00421-019-04104-x. Epub 2019 Mar 4.

  PMID: 30830277 BACKGROUND

• Dzik KP, Skrobot W, Kaczor KB, Flis DJ, Karnia MJ, Libionka W, Antosiewicz J, Kloc W, Kaczor JJ. Vitamin D Deficiency Is Associated with Muscle Atrophy and Reduced Mitochondrial Function in Patients with Chronic Low Back Pain. Oxid Med Cell Longev. 2019 Jun 2;2019:6835341. doi: 10.1155/2019/6835341. eCollection 2019.

  PMID: 31281588 BACKGROUND

• Pludowski P, Holick MF, Grant WB, Konstantynowicz J, Mascarenhas MR, Haq A, Povoroznyuk V, Balatska N, Barbosa AP, Karonova T, Rudenka E, Misiorowski W, Zakharova I, Rudenka A, Lukaszkiewicz J, Marcinowska-Suchowierska E, Laszcz N, Abramowicz P, Bhattoa HP, Wimalawansa SJ. Vitamin D supplementation guidelines. J Steroid Biochem Mol Biol. 2018 Jan;175:125-135. doi: 10.1016/j.jsbmb.2017.01.021. Epub 2017 Feb 12.

  PMID: 28216084 BACKGROUND

• Licking N, Murchison C, Cholerton B, Zabetian CP, Hu SC, Montine TJ, Peterson-Hiller AL, Chung KA, Edwards K, Leverenz JB, Quinn JF. Homocysteine and cognitive function in Parkinson's disease. Parkinsonism Relat Disord. 2017 Nov;44:1-5. doi: 10.1016/j.parkreldis.2017.08.005. Epub 2017 Aug 9.

  PMID: 28807493 BACKGROUND

• Sorgdrager FJH, Vermeiren Y, Van Faassen M, van der Ley C, Nollen EAA, Kema IP, De Deyn PP. Age- and disease-specific changes of the kynurenine pathway in Parkinson's and Alzheimer's disease. J Neurochem. 2019 Dec;151(5):656-668. doi: 10.1111/jnc.14843. Epub 2019 Aug 25.

  PMID: 31376341 BACKGROUND

• Arfa-Fatollahkhani P, Safar Cherati A, Habibi SAH, Shahidi GA, Sohrabi A, Zamani B. Effects of treadmill training on the balance, functional capacity and quality of life in Parkinson's disease: A randomized clinical trial. J Complement Integr Med. 2019 Aug 21;17(1):/j/jcim.2019.17.issue-1/jcim-2018-0245/jcim-2018-0245.xml. doi: 10.1515/jcim-2018-0245.

  PMID: 31433785 BACKGROUND

• Brienesse LA, Emerson MN. Effects of resistance training for people with Parkinson's disease: a systematic review. J Am Med Dir Assoc. 2013 Apr;14(4):236-41. doi: 10.1016/j.jamda.2012.11.012. Epub 2013 Jan 11.

  PMID: 23318666 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Parkinson Disease; Motor Activity

Interventions

Cholecalciferol; Plant Oils

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Zofia K Bytowska, MSc

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 24, 2021
• Study Start: November 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: February 28, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

PL (1)