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Vitamin B12 Supplement to Prevent Cognitive Decline

NCT02457507 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2016-01-28

No results posted yet for this study

Summary

Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic people. Vitamin B12 deficiency in older people is associated with cognitive impairment and Alzheimer's disease. Vitamin B12 deficiency may therefore contribute to cognitive decline in older diabetic people.

Objective: To determine whether the correction of mild vitamin B12 deficiency in cognitively normal older diabetic people reduces the incidence of cognitive decline.

Design: randomized, double blind, placebo controlled trial Subject: Cognitively normal diabetic outpatients aged 70 years or older with plasma vitamin B12 150-300 pmol/L in medical and family medicine/ general outpatient clinics.

Procedure: After excluding those with clinical manifestations of vitamin B12 deficiency and without family member who can reliably inform on cognitive functioning (personal contact at least once a week), eligible patients will be invited to participate in this clinical trial. After obtaining written consent, research assistant (RA) will record demographic and clinical information from the subjects and perform neuropsychological tests - 1. Clinical dementia rating scale (CDR), 2. neurocognitive test battery (see below) 3. Chinese Mini mental state examination (MMSE), 4. Geriatric depression scale (GDS). Fasting blood will be taken for serum methylmalonic acid (MMA). Those with cognitive impairment and significant comorbidities will be excluded.

264 eligible subjects will be randomly assigned to take either two Vitamin B12 500 microgram or two identical looking placebo tablets once daily for 27 months.

All subjects or family caregivers are reviewed in the research clinic every 12 weeks in which the research assistant performs a pill count and dispenses the trial tablets. At 9 monthly intervals, the subjects will have neurocognitive test battery repeated at research clinic. CDR will be repeated at month 18 and 27. At month 9 and 27, fasting serum MMA and vitamin B12 will be repeated.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin B12

2 tablets

DIETARY_SUPPLEMENT

Placebo

2 tablets

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02457507 on ClinicalTrials.gov