Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People - Full Text View

Sponsors and Collaborators:	Wageningen University ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00111267

Purpose

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	Intervention
Cognitive Decline Cognitive Symptoms	Behavioral: vitamin B12 supplementation Behavioral: vitamin B12 + folic acid combined supplementation

Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study

Further study details as provided by Wageningen University:

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

Estimated Enrollment:	165
Study Start Date:	May 2003
Estimated Study Completion Date:	January 2005

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111267

Locations

Netherlands, Gelderland
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV

Sponsors and Collaborators

Wageningen University

ZonMw: The Netherlands Organisation for Health Research and Development

More Information

Study ID Numbers:	P03.0277L, ZonMW 2100.0067
Study First Received:	May 18, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00111267
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:

vitamin B12
cognitive function
oral supplementation
elderly

Study placed in the following topic categories:

Folic Acid
Signs and Symptoms
Hydroxocobalamin

Vitamin B 12
Neurologic Manifestations
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009