Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive function of demented subjects with hyperhomocysteinaemia in a pilot study. Objective: To determine the effectiveness of vitamin B12 and folate supplementation in preserving cognitive function of subjects with early dementia
After stratified randomization by mini mental state examination scores, supplement group subjects take 1 mg of methylcobalamin and 5 mg of folic acid daily, while placebo group subjects take placebo capsules. The primary outcome is Mattis dementia rating scale. The secondary outcomes are mini mental state examination, neuropsychiatric inventory, and Cornell scale for depression in dementia. These measurements will be performed at baseline and every six months for 24 months. Fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
dementia rating scale
Time frame: at 6 months, 12 months and 18 months
depression rating scale
Time frame: at 6 months, 12 months and 18 months
vitamin b12
Time frame: at 18 months
folate
Time frame: at 18 months
homocysteine
Time frame: at 18 months
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