Alzheimer's DiseaseDEVIT-ALZNCT01420315
The Prevalence of Vitamin D Deficiency in Patients With Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Recent studies indicate that there is a relationship between cognitive decline and vitamin D deficiency. Up to now, no study has investigated the prevalence of vitamin d deficiency in patient with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 502 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2011to Aug 2012
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with Alzheimer's dementia will be included in the study.
Who may be able to join
- The patient must have Alzheimer's dementia and their diagnosis must be made according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS/ADRDA) and DSM-IV criteria
- The informed consent form must be given by patients and/or their representatives
Who cannot join
- if the causes of dementia (lewy body dementia, vascular dementia, pick disease, frontotemporal dementia...) is out of Alzheimer's dementia,
- having chronic liver disease and/or end-stage renal disease
- if the informed consent form is being withdrawn
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Medical School Training Hospital
Ankara, 06018
About this study
Official title: The Prevalence of Vitamin D Deficiency in Patients With Alzheimer's Disease: a Crosssectional Multicenter Study in Turkey
Recent studies indicate that there is a relationship between cognitive decline and vitamin D deficiency. Up to now, no study has investigated the prevalence of vitamin d deficiency in patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D deficiency and analysis the associated characteristics in patients with Alzheimer's disease.
Read the detailed description
Vitamin D has many physiological functions via skeletal and extra-skeletal effects. Nowadays, it is well known that vitamin d deficiency causes to an increase in disease burden. As the role of vitamin D, the maintenance of balance, the improvement of muscle power, and the augmentation of innate immunity were proven. Some recent studies showed that vitamin D deficiency associates with cardiovascular diseases, autoimmune diseases, and the risk of cancer.
Vitamin D carries out your functions by vitamin d receptors (VDR) located in many cells. Brain neurons and glial cells are including VDR's. It is presumed that the functions of vitamin d in neurons are the regulation of neurotransmission, neuron protection, and immunomodulation. Also,vitamin D has a role in brain development and maturation. Except the functions in central nerve system, vitamin D has effects on peripheral nerve system. It was reported that nerve transduction velocity decreased in vitamin d deficiency.
Vitamin D deficiency and Alzheimer's disease are major public health problems that their incidences increase in advanced ages.Recent studies indicate that there is a relationship between cognitive decline and vitamin D deficiency. VDR receptors in brain specially in hippocampus, hypothalamus, limbic system, subcortical and spinal motor areas were determined.
Up to now, no study has investigated the prevalence of vitamin d deficiency in patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D deficiency and analysis the associated characteristics in patients with Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Keywords
- vitamin D, deficiency, alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25(OH)D levels
Measured: January, 1, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ilkin Naharci, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Ilkin M Naharci, specialist, Study director, Gulhane Medical Faculty Training Hospital, Department of Internal Medicine, Division of Geriatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420315
- Sponsor's protocol ID
- VDGT-01
- Other IDs
- G-123456789
- Acronym
- DEVIT-ALZ
- Status last verified
- Feb 2013
- First submitted
- 18 Aug 2011
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Vitamin D Deficiency in Patients With Alzheimer's Disease: a Crosssectional Multicenter Study in Turkey
- ClinicalTrials.gov ID
- NCT01420315
- Acronym / sponsor ID
- DEVIT-ALZ / VDGT-01
- Conditions
- Alzheimer's Disease
- Keywords
- vitamin D, deficiency, alzheimer's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Aug 2011 (estimated)
- 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.
Recent studies indicate that there is a relationship between cognitive decline and vitamin D deficiency. Up to now, no study has investigated the prevalence of vitamin d deficiency in patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D deficiency and analysis the associated characteristics in patients with Alzheimer's disease.
Detailed description
Vitamin D has many physiological functions via skeletal and extra-skeletal effects. Nowadays, it is well known that vitamin d deficiency causes to an increase in disease burden. As the role of vitamin D, the maintenance of balance, the improvement of muscle power, and the augmentation of innate immunity were proven. Some recent studies showed that vitamin D deficiency associates with cardiovascular diseases, autoimmune diseases, and the risk of cancer.
Vitamin D carries out your functions by vitamin d receptors (VDR) located in many cells. Brain neurons and glial cells are including VDR's. It is presumed that the functions of vitamin d in neurons are the regulation of neurotransmission, neuron protection, and immunomodulation. Also,vitamin D has a role in brain development and maturation. Except the functions in central nerve system, vitamin D has effects on peripheral nerve system. It was reported that nerve transduction velocity decreased in vitamin d deficiency.
Vitamin D deficiency and Alzheimer's disease are major public health problems that their incidences increase in advanced ages.Recent studies indicate that there is a relationship between cognitive decline and vitamin D deficiency. VDR receptors in brain specially in hippocampus, hypothalamus, limbic system, subcortical and spinal motor areas were determined.
Up to now, no study has investigated the prevalence of vitamin d deficiency in patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D deficiency and analysis the associated characteristics in patients with Alzheimer's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with Alzheimer's dementia will be included in the study.
Key inclusion criteria (2 listed)
- The patient must have Alzheimer's dementia and their diagnosis must be made according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS/ADRDA) and DSM-IV criteria
- The informed consent form must be given by patients and/or their representatives
Key exclusion criteria (3 listed)
- if the causes of dementia (lewy body dementia, vascular dementia, pick disease, frontotemporal dementia...) is out of Alzheimer's dementia,
- having chronic liver disease and/or end-stage renal disease
- if the informed consent form is being withdrawn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum 25(OH)D levels
Time frame: January, 1, 2013
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 18 Feb 2013.
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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.
Ilkin M Naharci, specialist study director
Gulhane Medical Faculty Training Hospital, Department of Internal Medicine, Division of Geriatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 18 Feb 2013. 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 Turkey (Türkiye). 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. 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?
serum 25(OH)D levels (time frame: January, 1, 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2013.