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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02457507
Other study ID # DM-B12
Secondary ID
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


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
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