Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

Sponsor

Wageningen University (Other)

Overall Status

Completed

CT.gov ID

NCT00111267

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

165

Enrollment

Location

20.1

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Decline Cognitive Symptoms	Behavioral: vitamin B12 supplementation Behavioral: vitamin B12 + folic acid combined supplementation	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2003

Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Cognitive performance in the domains of attention, concentration, memory, executive function, speed []

Secondary Outcome Measures

Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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