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

Primary Purpose

Dementia

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Vitamin B12

folate

Sponsored by

Chinese University of Hong Kong

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Chinese University of Hong Kong

Outcomes

Primary Outcome Measures

dementia rating scale

depression rating scale

Secondary Outcome Measures

vitamin b12

folate

homocysteine

Full Information

NCT ID

First Posted

September 12, 2005

Last Updated

February 2, 2009

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00164970

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

166 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin B12

Intervention Type

Dietary Supplement

Intervention Name(s)

folate

Primary Outcome Measure Information:

Title

dementia rating scale

Time Frame

at 6 months, 12 months and 18 months

Title

depression rating scale

Time Frame

at 6 months, 12 months and 18 months

Secondary Outcome Measure Information:

Title

vitamin b12

Time Frame

at 18 months

Title

folate

Time Frame

at 18 months

Title

homocysteine

Time Frame

at 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy CY Kwok, MD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Chinese University of Hong Kong

City

Hong Kong

State/Province

Hong Kong

Country

China

12. IPD Sharing Statement

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

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