B-vitamins Treatment for Improvement of Cognitive Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2009-12-31

Brief Summary

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Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.

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Detailed Description

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We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.

Conditions

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Cognitive Function Metabolic Improvements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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B-Vitamins

folic acid, cobalamin, vitamin B6

Group Type ACTIVE_COMPARATOR

B-vitamin complex

Intervention Type DRUG

5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily

placebo

none of the vitamins (99.5% mannitol)

Group Type PLACEBO_COMPARATOR

B-vitamin complex

Intervention Type DRUG

5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily

Interventions

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B-vitamin complex

5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily

Intervention Type DRUG

Other Intervention Names

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no other names

Eligibility Criteria

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Inclusion Criteria

* age \> 65 years and glomerular filtration rate (GFR) \> 35 ml/min

Exclusion Criteria

* acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study.
* furthermore, people who had dementia (mini-mental state-examination scores MMSE \< 15)
* those treated with B-vitamins
* those with renal insufficiency
* those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No