Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?

Phase 4

Completed

• Conditions: Dementia

• Registration Number: NCT00164970
• Lead Sponsor: Chinese University of Hong Kong

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

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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-02
• Last Update Posted: 2009-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Dementia of Alzheimer's or vascular type
• Early dementia defined by Clinical Dementia Rating of 1.

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Exclusion Criteria

• lives alone
• significant communication problems
• significant co-existing diseases
• blood tests:vitamin B12< 150 pmol/l, serum creatinine> 250 mol/l, hypothyroidism and syphilis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
dementia rating scale	at 6 months, 12 months and 18 months
depression rating scale	at 6 months, 12 months and 18 months

Secondary Outcome Measures

Name	Time	Method
vitamin b12	at 18 months
folate	at 18 months
homocysteine	at 18 months

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇨🇳 Hong Kong, Hong Kong, China