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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B12 | Dietary Supplement | |||
| folate | Dietary Supplement |
| Measure | Description | Time Frame |
|---|---|---|
| dementia rating scale | at 6 months, 12 months and 18 months | |
| depression rating scale | at 6 months, 12 months and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| vitamin b12 | at 18 months | |
| folate | at 18 months | |
| homocysteine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy CY Kwok, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong | China |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| at 18 months |
| D001523 | Mental Disorders |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |