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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
Participants will be divided randomly into 2 groups: a control group and supplemented group.
Supplementation will last for 12 weeks.
Supplementation of vitamin D3 will be based on the participants Body Mass Index (BMI). The BMI will be measured by using the TANITA scale. The doses will be as followed: for BMI under 25 - 4000 International Units (IU)/day, for BMI between 25 and 30 - 5000 IU/day, and for BMI over 30 - 6000 IU/day. The placebo and control group will receive matching placebo treatment. Vitamin D3 as well as placebo will be in the same bottles with no labels on them.
Participants will be prompted to do 3500 steps per day in the first week of the research and finish the research with making 8000 per day. Participants will be obligated to measure the amount of steps by their phones.
There will be three meetings with the participants. On the first one there will be blood collection, participants will obtain questionnaires, about their daily activity and diet, to complete at home. Participants will have to sign the agreement of taking part in the research and perform functional tests. Also they will get their first supplementation bottles. On the second one the questionnaires will be collected, functional tests will be performed and supplementation will be replenished. On the third one the blood will be collected for the second time and functional tests will be performed again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •agreement to take part in a research,
- •Subthalamic nucleus deep brain stimulation (STN-DBS) treatment,
- •willingness to work.
排除标准
- •supplementation of vitamin D before the research,
- •serious comorbidity (like tumour, cerebrovascular disease, cardiorespiratory compromise, forced dementia).
研究组 & 干预措施
Control group
The group will receive placebo treatment.
干预措施: Placebo (Drug)
Vitamin D3 group
The group will receive vitamin D3 supplementation.
干预措施: Juvit D3 (Drug)
结局指标
主要结局
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
时间窗: 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.
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
时间窗: 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).
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
时间窗: 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.
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
时间窗: 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.
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
时间窗: 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.
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
时间窗: 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 kynurenine pathway metabolites will be assessed by using liquid chromatography coupled with tandem mass spectrometry technique (LC-MS/MS).
次要结局
未报告次要终点