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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:

MedlinePlus related topics: B Vitamins Dementia
U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 16, 2013