Vitamin D Supplementation and Neurocognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2020-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the effect of vitamin D supplementation on the neurocognitive function of older people with lower than normal levels of vitamin D at baseline

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02381600

VITAMIN D DEFICIENCY

TERMINATED NA

Improving Functionality in Older People

NCT03611049

Vitamin D Deficiency

TERMINATED PHASE2

Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults

NCT02804841

Healthy

COMPLETED NA

Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint

NCT02185222

Memory Disorders Age-Related Cognitive Decline

COMPLETED PHASE3

Interventional Trial of Vitamin D Deficiency in the Patients of General Departments

NCT00640237

Vitamin D Deficiency

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: Ageing is associated with an increased risk of cognitive decline. 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 cognitive function of older people. The investigators propose a pilot study to evaluate the effect of vitamin D supplementation on the neurocognitive function of older people.

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 included in the study. Exclusion criteria will include any unstable medical condition as determined by the treating physician, a diagnosis of dementia, 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 the performance of computerized neurocognitive testing. Following provision of written informed consent for inclusion in the study, subjects will answer a questionnaire providing demographic details, undergo cognitive screening by use of the MoCA test, and computerized cognitive assessment using the Neurotrax battery. 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. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3). At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax battery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency Neurocognitive Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Comparator: Intervention group

Vitamin D supplementation for subjects with below normal levels of this vitamin.

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

1. Subjects will undergo a cognitive evaluation using the Montreal Cognitive Assessment (MoCA) screening test and the Neurotrax computerized cognitive assessment battery.
2. Subjects will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months.
3. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3).
4. Subjects will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up.
5. At 3-month follow-up subjects will be asked to complete the Neurotrax computerized cognitive assessment battery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

1. Subjects will undergo a cognitive evaluation using the Montreal Cognitive Assessment (MoCA) screening test and the Neurotrax computerized cognitive assessment battery.
2. Subjects will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months.
3. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3).
4. Subjects will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up.
5. At 3-month follow-up subjects will be asked to complete the Neurotrax computerized cognitive assessment battery.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults aged 65 years and older.
* Level of vitamin D (25-OH vitamin D) is less than 30 ng / ml.
* Stable health status as assessed by the treating primary care physician.
* Do not take supplements containing vitamin D.
* Normal cognitive function as determined by MoCA Test screening and clinical assessment
* Adequate literacy to enable the performance of cognitive assessment instruments
* Provide informed consent as required by the Ethics Committee.

Exclusion Criteria

* Age younger than 65 years
* Health status not stable as determined by the treating primary care physician
* A diagnosis of dementia
* Taking supplements containing Vitamin D
* Significant visual or hearing impairment not corrected by spectacles or hearing aids
* Impaired competency limiting the subject's ability to provide informed consent

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No