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

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ClinicalTrials.gov Identifier: NCT00164970
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 3, 2009
Sponsor:
Information provided by:
Chinese University of Hong Kong

Study Description
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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


Condition or disease Intervention/treatment Phase
Dementia Dietary Supplement: Vitamin B12 Dietary Supplement: folate Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
Study Start Date : October 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. vitamin b12 [ Time Frame: at 18 months ]
  2. folate [ Time Frame: at 18 months ]
  3. homocysteine [ Time Frame: at 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164970


Locations
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China, Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Timothy CY Kwok, MD Chinese University of Hong Kong
More Information
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ClinicalTrials.gov Identifier: NCT00164970    
Other Study ID Numbers: RCT-B12
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Vitamin B 12
 Hydroxocobalamin
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex
Hematinics