Vitamin D Supplementation and Neurocognition

NCT03019120 | Withdrawn Phase 2

• 1 other identifier: 0103-16-LND
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D Deficiency; Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function as assessed by the Neurotrax computerized cognitive assessment battery

  The Neurotrax computerized cognitive assessment instrument measures the following domains: Memory, executive functions, attention, verbal functions and motor skills. This instrument was found to have high validity in identifying patients who suffer from cognitive decline in comparison to healthy patients in the elderly. There are many advantages to a computerized cognitive assessment tool. It allows a measurement of various cognitive domains as well as an accurate, detailed and objective measurements of patients. It is also very sensitive to cognitive changes occurring in a specific individual over time.

  3 months

Study Arms (1)

Active Comparator: Intervention group

EXPERIMENTAL

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

Drug: Vitamin D

Interventions

Vitamin D 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.

Active Comparator: Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Laniado Medical Center

Netanya, Israel

Location

Related Publications (4)

• Annweiler C, Allali G, Allain P, Bridenbaugh S, Schott AM, Kressig RW, Beauchet O. Vitamin D and cognitive performance in adults: a systematic review. Eur J Neurol. 2009 Oct;16(10):1083-9. doi: 10.1111/j.1468-1331.2009.02755.x. Epub 2009 Jul 29.

  PMID: 19659751 BACKGROUND

• Buell JS, Dawson-Hughes B. Vitamin D and neurocognitive dysfunction: preventing "D"ecline? Mol Aspects Med. 2008 Dec;29(6):415-22. doi: 10.1016/j.mam.2008.05.001. Epub 2008 May 13.

  PMID: 18579197 BACKGROUND

• Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.

  PMID: 14594456 BACKGROUND

• Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.

  PMID: 23124009 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Cognition Disorders

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Elad Rubin, M.A

  Rambam Health Care Campus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 12, 2017
• Study Start: January 15, 2017
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)