Vitamin D DeficiencyNCT04768023
12 Weeks Vitamin D Supplementation and Physical Activity in PD Patients With DBS
A study testing Juvit D3 in people with Vitamin D Deficiency and Parkinson Disease, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Vitamin D Deficiency, Parkinson Disease
- What is being tested?
- Juvit D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2019to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- agreement to take part in a research,
- Subthalamic nucleus deep brain stimulation (STN-DBS) treatment,
- willingness to work.
Who cannot join
- supplementation of vitamin D before the research,
- serious comorbidity (like tumour, cerebrovascular disease, cardiorespiratory compromise, forced dementia).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the detailed description
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.
The questionnaire about daily activity will be International Physical Activity Questionnaire - Short Form.
The questionnaire about diet will be "Kwestionariusz QEB opracowany przez Zespół Behawioralnych Uwarunkowań Żywienia, Komitet Nauki o Żywieniu Człowieka, PAN". (Only polish version is available)
The blood will be collected into test tubes with clot activator, then centrifuged at 4000×g for 10 min at 4oC. The obtained serum samples will be stored in dark at -80oC until the analysis.
Investigators want to measure the changes in concentrations in blood of 25-hydroxycholecalciferol (25-OH D3), vitamin D3 binding protein, homocysteine, calcium, parathormone, interleukin-2 (IL-2), interleukin-6 (IL-6), interleukin-15 (IL-15), C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), serotonin, and the chosen markers of kynurenine pathway.
The functional tests will be assessed: 6 minute walk test (6MWT), test up\&go (TUG) and 10 m walk test (10MWT). All tests will be performed in the on-phase of their usual anti-PD medications. All tests will be explained and demonstrated before they will be taken. If the first attempt will go well participant will follow to the next one. If any mistake will appear, participant will wait for a minute and try again. During every meeting the procedure of each test will be remind to the participants.
The 6MWT will be administered in a 15m line at the corridor. Participants will be instructed to go back and forth along without running the 15m line as far as they can in 6 min. The total distance will be measured after 6 min.
In TUG participants will be supposed to stand up from the chair, walk 3m, turn around, go back to the chair and sit down as fast as they can without running.
In 10MWT investigators will measure the time which takes the participants to walk through 10m form standing position.
- Conditions
- Vitamin D Deficiency, Parkinson Disease
- Being tested
- Juvit D3, Placebo
- Keywords
- parkinson's disease, deep brain stimulation, vitamin D, physical activity, functional tests, homocysteine, inflammatory markers, kynurenine pathway
- Medical subject headings
- Vitamin D Deficiency, Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvit D3Drug
Also called vitamin 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.
PlaceboDrug
Also called Vegetable oil
Matching amount of vegetable oil to the vitamin D3.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The group will receive placebo treatment. Receives: Drug: Placebo |
| Vitamin D3 group | Experimental | The group will receive vitamin D3 supplementation. Receives: Drug: Juvit D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: The outcome measure will be assessed up to 1 year after the last participant will go under the second collection of blood.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Nov 2019
- Primary completion30 Apr 2020
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zofia K Bytowska, MSc, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768023
- Sponsor's protocol ID
- PD2019/2022
- Status last verified
- Sep 2023
- First submitted
- 14 Feb 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31389495Aum 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.
PubMed 28930542Dzik 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.
PubMed 30830277Dzik 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.
PubMed 31281588Pludowski 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.
PubMed 28216084Licking 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.
PubMed 28807493Sorgdrager 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.
PubMed 31376341Arfa-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.
PubMed 31433785Brienesse 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.
PubMed 23318666
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04768023
- Acronym / sponsor ID
- PD2019/2022
- Conditions
- Vitamin D Deficiency, Parkinson Disease
- Keywords
- parkinson's disease, deep brain stimulation, vitamin D, physical activity, functional tests, homocysteine, inflammatory markers, kynurenine pathway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
The questionnaire about daily activity will be International Physical Activity Questionnaire - Short Form.
The questionnaire about diet will be "Kwestionariusz QEB opracowany przez Zespół Behawioralnych Uwarunkowań Żywienia, Komitet Nauki o Żywieniu Człowieka, PAN". (Only polish version is available)
The blood will be collected into test tubes with clot activator, then centrifuged at 4000×g for 10 min at 4oC. The obtained serum samples will be stored in dark at -80oC until the analysis.
Investigators want to measure the changes in concentrations in blood of 25-hydroxycholecalciferol (25-OH D3), vitamin D3 binding protein, homocysteine, calcium, parathormone, interleukin-2 (IL-2), interleukin-6 (IL-6), interleukin-15 (IL-15), C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), serotonin, and the chosen markers of kynurenine pathway.
The functional tests will be assessed: 6 minute walk test (6MWT), test up\&go (TUG) and 10 m walk test (10MWT). All tests will be performed in the on-phase of their usual anti-PD medications. All tests will be explained and demonstrated before they will be taken. If the first attempt will go well participant will follow to the next one. If any mistake will appear, participant will wait for a minute and try again. During every meeting the procedure of each test will be remind to the participants.
The 6MWT will be administered in a 15m line at the corridor. Participants will be instructed to go back and forth along without running the 15m line as far as they can in 6 min. The total distance will be measured after 6 min.
In TUG participants will be supposed to stand up from the chair, walk 3m, turn around, go back to the chair and sit down as fast as they can without running.
In 10MWT investigators will measure the time which takes the participants to walk through 10m form standing position.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: PlaceboThe group will receive placebo treatment. |
| Vitamin D3 group | Experimental | Drug: Juvit D3The group will receive vitamin D3 supplementation. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- agreement to take part in a research,
- Subthalamic nucleus deep brain stimulation (STN-DBS) treatment,
- willingness to work.
Key exclusion criteria (2 listed)
- supplementation of vitamin D before the research,
- serious comorbidity (like tumour, cerebrovascular disease, cardiorespiratory compromise, forced dementia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juvit D3Also: vitamin D3Dosage 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. | Drug | Vitamin D3 group |
| PlaceboAlso: Vegetable oilMatching amount of vegetable oil to the vitamin D3. | Drug | Control group |
Primary outcome
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).
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.
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.
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.
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.
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
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 kynurenine pathway metabolites will be assessed by using liquid chromatography coupled with tandem mass spectrometry technique (LC-MS/MS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 31389495da 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.
- Background: PubMed 28930542Aum 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.
- Background: PubMed 30830277Dzik 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.
- Background: PubMed 31281588Dzik 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.
- Background: PubMed 28216084Pludowski 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.
- Background: PubMed 28807493Licking 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.
- Background: PubMed 31376341Sorgdrager 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.
- Background: PubMed 31433785Arfa-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.
- Background: PubMed 23318666Brienesse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zofia K Bytowska, MSc principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juvit D3 in people with Vitamin D Deficiency and Parkinson Disease, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768023, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.