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Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

NCT ID: NCT00111267

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Cognitive Decline Cognitive Symptoms

Keywords

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vitamin B12 cognitive function oral supplementation elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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vitamin B12 supplementation

Intervention Type BEHAVIORAL

vitamin B12 + folic acid combined supplementation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Locations

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Wageningen University

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ZonMW 2100.0067

Identifier Type: -

Identifier Source: secondary_id

P03.0277L

Identifier Type: -

Identifier Source: org_study_id