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The Prevalence of Vitamin D Deficiency in Patients With Alzheimer's Disease (DEVIT-ALZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420315
First Posted: August 19, 2011
Last Update Posted: February 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mehmet Ilkin Naharci, Gulhane Military Medical Academy
  Purpose
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.

Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Prevalence of Vitamin D Deficiency in Patients With Alzheimer's Disease: a Crosssectional Multicenter Study in Turkey

Resource links provided by NLM:


Further study details as provided by Mehmet Ilkin Naharci, Gulhane Military Medical Academy:

Primary Outcome Measures:
  • serum 25(OH)D levels [ Time Frame: January, 1, 2013 ]

Enrollment: 502
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients with Alzheimer's dementia will be included in the study.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420315


Locations
Turkey
Gulhane Medical School Training Hospital
Ankara, Turkey, 06018
Sponsors and Collaborators
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Investigators
Study Director: Ilkin M Naharci, specialist Gulhane Medical Faculty Training Hospital, Department of Internal Medicine, Division of Geriatrics
  More Information

Responsible Party: Mehmet Ilkin Naharci, Assistant professor, Gulhane Military Medical Academy
ClinicalTrials.gov Identifier: NCT01420315     History of Changes
Other Study ID Numbers: VDGT-01
G-123456789 ( Other Identifier: Gulhane Medical Training School )
First Submitted: August 18, 2011
First Posted: August 19, 2011
Last Update Posted: February 18, 2013
Last Verified: February 2013

Keywords provided by Mehmet Ilkin Naharci, Gulhane Military Medical Academy:
vitamin D
deficiency
alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Vitamin D Deficiency
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents