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OpenTrials
Completed

NCT Number: NCT00164970

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

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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Chinese University of Hong Kong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B12

Dietary Supplement

Folate

Dietary Supplement

Primary outcomes

  1. dementia rating scale

    Time frame: at 6 months, 12 months and 18 months

  2. depression rating scale

    Time frame: at 6 months, 12 months and 18 months

Secondary outcomes

  1. vitamin b12

    Time frame: at 18 months

  2. folate

    Time frame: at 18 months

  3. homocysteine

    Time frame: at 18 months

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2005
Registry last updated
Feb 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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