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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00164970

Enrollment

166

Registered

2005-09-14

Start date

2004-10-31

Completion date

2008-12-31

Last updated

2009-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

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.

Interventions

DIETARY_SUPPLEMENTVitamin B12

DIETARY_SUPPLEMENTfolate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
dementia rating scale	at 6 months, 12 months and 18 months
depression rating scale	at 6 months, 12 months and 18 months

Secondary

Measure	Time frame
homocysteine	at 18 months
vitamin b12	at 18 months
folate	at 18 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026