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

February 2, 2009 updated by: Chinese University of Hong Kong

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

Study Overview

Status

Completed

Conditions

Dementia

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

166

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Hong Kong
  - Hong Kong, Hong Kong, China
    - The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
dementia rating scale Time Frame: at 6 months, 12 months and 18 months	at 6 months, 12 months and 18 months
depression rating scale Time Frame: at 6 months, 12 months and 18 months	at 6 months, 12 months and 18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
vitamin b12 Time Frame: at 18 months	at 18 months
folate Time Frame: at 18 months	at 18 months
homocysteine Time Frame: at 18 months	at 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria