Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00111267

Enrollment

165

Registered

2005-05-19

Start date

2003-05-31

Completion date

2005-01-31

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Cognitive Symptoms

Keywords

vitamin B12, cognitive function, oral supplementation, elderly

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 with mild vitamin B12 deficiency.

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 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.

Interventions

BEHAVIORALvitamin B12 supplementation

BEHAVIORALvitamin B12 + folic acid combined supplementation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cognitive performance in the domains of attention, concentration, memory, executive function, speed	—

Secondary

Measure	Time frame
Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026