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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00164983
First received: September 12, 2005
Last updated: NA
Last verified: January 2003
History: No changes posted
  Purpose

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
Dementia
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
  Eligibility

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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00164983

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

No publications provided

ClinicalTrials.gov Identifier: NCT00164983     History of Changes
Other Study ID Numbers: OL-methylcobal
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Dementia
Hyperhomocysteinemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Avitaminosis
Malnutrition
Nutrition Disorders
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014