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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164970
• Other study ID #: RCT-B12
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 2, 2009
• Start date: October 2004
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Dementia of Alzheimer's or vascular type

• Early dementia defined by Clinical Dementia Rating of 1.

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

Dietary Supplement:
• Vitamin B12

• folate

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dementia rating scale		at 6 months, 12 months and 18 months
Primary	depression rating scale		at 6 months, 12 months and 18 months
Secondary	vitamin b12		at 18 months
Secondary	folate		at 18 months
Secondary	homocysteine		at 18 months