Vitamin B12 Supplement to Prevent Cognitive Decline
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|ClinicalTrials.gov Identifier: NCT02457507|
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : January 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Decline||Dietary Supplement: Vitamin B12 Dietary Supplement: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||271 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Vitamin B12
Vitamin B12, 1mg, daily, 27 months
Dietary Supplement: Vitamin B12
Placebo Comparator: Placebo
Dietary Supplement: Placebo
- Change in Clinical Dementia Rating Scale (CDR) [ Time Frame: Change from baseline in CDR at month 9, 18, 27 ]
- Change in Neurocognitive test battery (NTB) score [ Time Frame: Change from baseline in NTB score at month 9, 18, 27 ]NTB including tests of executive funciton, psychomotor speed and memory
- Change in serum homocysteine (µmol/L) [ Time Frame: Change from baseline in serum homocysteine at month 9, 27 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457507
|The Chinese University of Hong Kong|
|Hong Kong, China|