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

This study has been completed.
Information provided by:
Chinese University of Hong Kong Identifier:
First received: September 12, 2005
Last updated: February 2, 2009
Last verified: February 2009

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 Intervention Phase
Dietary Supplement: Vitamin B12
Dietary Supplement: folate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?

Resource links provided by NLM:

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

Primary Outcome Measures:
  • dementia rating scale [ Time Frame: at 6 months, 12 months and 18 months ]
  • depression rating scale [ Time Frame: at 6 months, 12 months and 18 months ]

Secondary Outcome Measures:
  • vitamin b12 [ Time Frame: at 18 months ]
  • folate [ Time Frame: at 18 months ]
  • homocysteine [ Time Frame: at 18 months ]

Estimated Enrollment: 166
Study Start Date: October 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

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

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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Please refer to this study by its identifier: NCT00164970

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 Identifier: NCT00164970     History of Changes
Other Study ID Numbers: RCT-B12
Study First Received: September 12, 2005
Last Updated: February 2, 2009

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Folic Acid
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hematinics processed this record on April 27, 2017