An Evaluation of the Effect of Vitamin D Supplementation on the Cognitive Function of Older Subjects With Low Levels of This Vitamin

Summary

Background: Ageing is associated with an increased risk of cognitive decline and depression. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in affect and cognitive function in the elderly. The investigators propose a pilot study to examine the relationship between below-normal levels of Vitamin D to affective symptoms and specific cognitive functions in the elderly.

Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH Vitamin D lower than 30 ng/ml on routine laboratory screening will be referred by the treating family physicianfor screening. Subjects will be required to provide written informed consent for inclusion in the study. Exclusion criteria will include any active or unstable medical condition as determined by the treating physician, known neurocognitive disorder, known affective disorder, the use of any class of antidepressant drugs, the use of supplements containing vitamin D in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits cognitive ability. All subjects will undergo cognitive screening by use of the MoCA test, computerized cognitive assessment using the the Neurotrax (®Mindstreams) computerised cognitive assessment battery, and the 15-item Geriatric Depression Scale. All subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax Mindstreams battery and the 15-item Geriatric Depression Scale (GDS).

Conditions

• VITAMIN D DEFICIENCY

Interventions

DRUG

Vitamin D

Experimental : 1. Patients will undergo clinical and functional assessment as well as evaluation using the Montreal Cognitive Assessment (MoCA) screening test, the modified 15-item Geriatric Depression Scale, and the Neurotrax (®Mindstreams) computerised cognitive assessment battery. 2. Patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months Patients will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up. 3. At 3-month follow-up atients will be asked to complete the 15-item GDS and the Neurotrax (®Mindstreams) computerised cognitive assessment battery.

Sponsors & Collaborators

• Meir Medical Center

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2016-10-31

Completion

2016-10-31

Countries

• Israel

Study Locations