drugset / Trial / NCT04768023

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

NCT04768023

Completed 50 enrolled Medical University of Gdansk
RandomizedFactorialDouble-blindSupportive care

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).

Timeline

Start
2019-11-01
Primary completion
2020-04-30
Completion
2022-02-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 4000 iu
Subject Cholecalciferol Other / unclassified 5000 iu
Subject Cholecalciferol Other / unclassified 6000 iu