NCT00164970

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

Enrollment Period

4.2 years

First QC Date

September 12, 2005

Last Update Submit

February 2, 2009

Conditions

Dementia

Outcome Measures

Primary Outcomes (2)

  • dementia rating scale

    at 6 months, 12 months and 18 months

  • depression rating scale

    at 6 months, 12 months and 18 months

Secondary Outcomes (3)

  • vitamin b12

    at 18 months

  • folate

    at 18 months

  • homocysteine

    at 18 months

Interventions

Vitamin B12DIETARY_SUPPLEMENT
folateDIETARY_SUPPLEMENT

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Dementia

Interventions

Vitamin B 12Folic Acid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPterinsPteridinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Timothy CY Kwok, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

CN(1)