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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Ilkin Naharci, Gulhane Military Medical Academy
ClinicalTrials.gov Identifier:
NCT01420315
First received: August 18, 2011
Last updated: February 15, 2013
Last verified: February 2013
  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 Gulhane Military Medical Academy:

Primary Outcome Measures:
  • serum 25(OH)D levels [ Time Frame: January, 1, 2013 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420315

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

No publications provided

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
Study First Received: August 18, 2011
Last Updated: February 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014