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Completed

NCT Number: NCT00111267

Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

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 with mild vitamin B12 deficiency.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

About this study

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 absorption (active) of food-bound vitamin B12. In contrast, the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age. In both healthy and cognitively impaired elderly people, associations between vitamin B12 status and cognitive performance have been observed, and the follow-up of geriatric patients suggests effects of parenteral treatment in early cognitive impairment.

We investigated whether daily oral supplementation with 1,000 μg vitamin B12 or 1,000 μg vitamin B12 combined with 400 μg folate for 24 weeks improves cognitive performance in people over 70 years with vitamin B12 deficiency.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

vitamin B12 supplementation

Behavioral

vitamin B12 + folic acid combined supplementation

Behavioral

Primary outcomes

  1. Cognitive performance in the domains of attention, concentration, memory, executive function, speed

Secondary outcomes

  1. Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study

Important dates

Study start
2003
Study completion
2005
First posted
May 19, 2005
Registry last updated
Jun 24, 2005

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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