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Completed

NCT Number: NCT01095211

B-vitamins Treatment for Improvement of Cognitive Function

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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Key information

Conditions

Cognitive Function Metabolic Improvements

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Eckert-

Sankt Ingbert, Saarland, 66386, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-vitamin complex

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

Other names: no other names

Primary outcomes

  1. Cognitive function

    Time frame: baseline and 45 days later

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Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Collaborators

  • Geriatrische Rehaklinik

Registry information

Official study title

Effect of B-Vitamins on Cognitive Function in Elderly People

Important dates

Study start
2003
Primary completion
2005
Study completion
2009
First posted
Mar 30, 2010
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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