Vitamin B12 Supplement to Prevent Cognitive Decline

Cognitive Decline Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457507
• Other study ID #: DM-B12
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2015
• Last updated: January 26, 2016
• Start date: August 2011
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Hong Kong Hospital Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years to 100 Years

Eligibility

Inclusion Criteria:

• >/= 70 years old

• B12: 150 - 300 pmol/L

• Caregiver (personal contact at least once a week)

Exclusion Criteria:

• Dementia

• Peripheral neuropathy

• Anaemia (Hb<10 g/dl)

• Renal failure (creatinine > 150 µmol/L

• Stroke

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Decline

Intervention

Dietary Supplement:
• Vitamin B12
2 tablets
• Placebo
2 tablets

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Dementia Rating Scale (CDR)		Change from baseline in CDR at month 9, 18, 27	No
Secondary	Change in Neurocognitive test battery (NTB) score	NTB including tests of executive funciton, psychomotor speed and memory	Change from baseline in NTB score at month 9, 18, 27	No
Secondary	Change in serum homocysteine (µmol/L)		Change from baseline in serum homocysteine at month 9, 27	No