The Role of Methylcobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia ?

This study has been completed.
Information provided by:
Chinese University of Hong Kong Identifier:
First received: September 12, 2005
Last updated: September 14, 2015
Last verified: January 2003

Background:Vitamin B12 deficiency is common among older people, especially among the demented 1,2,3 because of poor diet, malabsorption, and drugs.

Objective: to examine the effect of correction of vitamin B12 deficiency on the cognitive function of patients with early dementia.

Condition Intervention Phase
Drug: methylcobal
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Methylcobalamin in Early Dementia Patients With Vitamin B12

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Dementia at 4 motnhs

Secondary Outcome Measures:
  • plasma homocysteine at 4 months
  • plasma isoprostane at 4 months

Estimated Enrollment: 29
Study Start Date: October 2003
Estimated Study Completion Date: August 2005

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • serum vitamin B12 level < 200 pmol/l

Exclusion Criteria:

  • significant communication problems - deafness, dysarthria, dysphasia etc.
  • unstable diabetes mellitus or hypertension
  • alcohol abuse
  • significant co-existing diseases which may affect cognitive, e.g. congestive cardiac failure, respiratory failure, Parkinson's disease etc.
  • folate < 10 nmol/l
  • haemoglobin concentration <10 g/dl
  • abnormal thyroid function test or VDRL
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Please refer to this study by its identifier: NCT00164983

China, Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Timothy CY Kwok, MD Chinese University of Hong Kong
  More Information

No publications provided Identifier: NCT00164983     History of Changes
Other Study ID Numbers: OL-methylcobal 
Study First Received: September 12, 2005
Last Updated: September 14, 2015
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Deficiency Diseases
Vitamin B Deficiency
Vitamin B 12
Vitamin B Complex
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Nutrition Disorders
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 11, 2016