Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
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Purpose
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 |
|---|---|---|
|
Dementia |
Dietary Supplement: Vitamin B12 Dietary Supplement: folate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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? |
- 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 ]
- 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) |
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| 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| China, Hong Kong | |
| The Chinese University of Hong Kong | |
| Hong Kong, Hong Kong, China | |
| Principal Investigator: | Timothy CY Kwok, MD | Chinese University of Hong Kong |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00164970 History of Changes |
| Other Study ID Numbers: | RCT-B12 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 2, 2009 |
| Health Authority: | Hong Kong: Department of Health |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Folic Acid Vitamin B Complex Vitamin B 12 |
Hydroxocobalamin Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013