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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00164970
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Duration (Months): 50
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Oct 1, 2004
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. dementia rating scale [at 6 months, 12 months and 18 months]

2. depression rating scale [at 6 months, 12 months and 18 months]

Secondary Outcome Measures

1. vitamin b12 [at 18 months]

2. folate [at 18 months]

3. homocysteine [at 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00164970
• Other Study ID Numbers: RCT-B12
• First Posted: Sep 14, 2005
• Last Update Posted: Feb 3, 2009
• Last Verified: Feb 1, 2009

• Additional relevant MeSH terms: Dementia; Vitamin B 12; Hydroxocobalamin

Study Results

No Results Posted as of Feb 3, 2009