B-vitamins Treatment for Improvement of Cognitive Function

Universität des Saarlandes79 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Cognitive Function Metabolic Improvements

Interventions

B-vitamin complexDRUG

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. Eckert-

Sankt Ingbert, Saarland, Germany

Outcomes

Primary Outcomes

Cognitive function

Time frame: baseline and 45 days later

Data from ClinicalTrials.gov

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