Study Results
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Basic Information
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COMPLETED
PHASE4
271 participants
INTERVENTIONAL
2011-08-31
2016-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Vitamin B12
Vitamin B12, 1mg, daily, 27 months
Vitamin B12
2 tablets
Placebo
Placebo comparator
Placebo
2 tablets
Interventions
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Vitamin B12
2 tablets
Placebo
2 tablets
Eligibility Criteria
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Inclusion Criteria
* B12: 150 - 300 pmol/L
* Caregiver (personal contact at least once a week)
Exclusion Criteria
* Peripheral neuropathy
* Anaemia (Hb\<10 g/dl)
* Renal failure (creatinine \> 150 µmol/L
* Stroke
70 Years
100 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Timothy Kwok
Professor
Locations
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The Chinese University of Hong Kong
Hong Kong, , China
Countries
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References
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Kwok T, Lee J, Ma RC, Wong SY, Kung K, Lam A, Ho CS, Lee V, Harrison J, Lam L. A randomized placebo controlled trial of vitamin B12 supplementation to prevent cognitive decline in older diabetic people with borderline low serum vitamin B12. Clin Nutr. 2017 Dec;36(6):1509-1515. doi: 10.1016/j.clnu.2016.10.018. Epub 2016 Oct 27.
Other Identifiers
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DM-B12
Identifier Type: -
Identifier Source: org_study_id
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