Vitamin B12 Supplement to Prevent Cognitive Decline

Phase 4

Completed

• Conditions: Cognitive Decline
• Interventions: Dietary Supplement: Vitamin B12; Dietary Supplement: Placebo

• Registration Number: NCT02457507
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-05-29
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

• >/= 70 years old
• B12: 150 - 300 pmol/L
• Caregiver (personal contact at least once a week)

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Exclusion Criteria

• Dementia
• Peripheral neuropathy
• Anaemia (Hb<10 g/dl)
• Renal failure (creatinine > 150 µmol/L
• Stroke

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin B12	Vitamin B12	Vitamin B12, 1mg, daily, 27 months
Placebo	Placebo	Placebo comparator

Primary Outcome Measures

Name	Time	Method
Change in Clinical Dementia Rating Scale (CDR)	Change from baseline in CDR at month 9, 18, 27

Secondary Outcome Measures

Name	Time	Method
Change in serum homocysteine (µmol/L)	Change from baseline in serum homocysteine at month 9, 27
Change in Neurocognitive test battery (NTB) score	Change from baseline in NTB score at month 9, 18, 27	NTB including tests of executive funciton, psychomotor speed and memory

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China