Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
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
Dietary Supplement: Vitamin B12
Dietary Supplement: folate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?|
- 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 ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164970
|China, Hong Kong|
|The Chinese University of Hong Kong|
|Hong Kong, Hong Kong, China|
|Principal Investigator:||Timothy CY Kwok, MD||Chinese University of Hong Kong|