Status:

COMPLETED

Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

Lead Sponsor:

Wageningen University

Collaborating Sponsors:

ZonMw: The Netherlands Organisation for Health Research and Development

Conditions:

Cognitive Decline

Cognitive Symptoms

Eligibility:

All Genders

70+ years

Phase:

NA

Brief Summary

The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people w...

Detailed Description

Mild vitamin B12 deficiency is highly prevalent in old age. Reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorpti...

Eligibility Criteria

Inclusion

  • Mild vitamin B12 deficiency:
  • Low plasma vitamin B12 concentration (100 \< B12 \< 300 pmol/L)
  • Elevated methylmalonic acid (MMA) concentration (\> 0.32 umol/L)
  • Creatinine concentration \< 120 umol/L

Exclusion

  • Severe cognitive impairment
  • Anemia
  • Gastrointestinal surgery or diseases
  • Use of vitamin B12 injections or supplements containing \> 25 ug vitamin B12 and/or 200 ug folic acid
  • \< 90% compliance during a 2 week placebo run in period
  • No written informed consent
  • Participation in other research studies

Key Trial Info

Start Date :

May 1 2003

Trial Type :

INTERVENTIONAL

End Date :

January 1 2005

Estimated Enrollment :

165 Patients enrolled

Trial Details

Trial ID

NCT00111267

Start Date

May 1 2003

End Date

January 1 2005

Last Update

June 24 2005

Active Locations (1)

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Wageningen University

Wageningen, Gelderland, Netherlands, 6700 EV