Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164970
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2005-09-12
Brief Title:
Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Objective To determine the effectiveness of vitamin B12 and folate supplementation in preserving cognitive function of subjects with early dementia
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None