Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00111267
First received: May 18, 2005
Last updated: June 23, 2005
Last verified: May 2005
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
Wageningen University
ZonMw: The Netherlands Organisation for Health Research and Development
  More Information

No publications provided

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

Keywords provided by Wageningen University:
vitamin B12
cognitive function
oral supplementation
elderly

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014