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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01420315
Other study ID # VDGT-01
Secondary ID G-123456789
Status Completed
Phase N/A
First received August 18, 2011
Last updated February 15, 2013
Start date August 2011
Est. completion date August 2012

Study information

Verified date February 2013
Source Gulhane Military Medical Academy
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical 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. Our aim is to investigate the prevalence of vitamin D deficiency and analysis the associated characteristics in patients with Alzheimer's disease.


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.


Recruitment information / eligibility

Status Completed
Enrollment 502
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
Turkey Gulhane Medical School Training Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gulhane Military Medical Academy

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum 25(OH)D levels January, 1, 2013 No
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