Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111267
• Other study ID #: P03.0277L
• Secondary ID: ZonMW 2100.0067
• Status: Completed
• Phase: N/A
• First received: May 18, 2005
• Last updated: June 23, 2005
• Start date: May 2003
• Est. completion date: January 2005

Study information

• Verified date: May 2005
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Symptoms
• Neurobehavioral Manifestations

Intervention

Behavioral:
• vitamin B12 supplementation

• vitamin B12 + folic acid combined supplementation

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance in the domains of attention, concentration, memory, executive function, speed
Secondary	Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate