Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
This study has been completed.
Sponsor:
Wageningen University
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
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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:
Drug Information available for:
Folic acid
Cyanocobalamin
Vitamin B Complex
Cobalamin
Hydroxocobalamin
U.S. FDA Resources
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 |
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 (Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00111267
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
| 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 Neurologic Manifestations Nervous System Diseases Signs and Symptoms Vitamins Folic Acid Vitamin B 12 |
Hydroxocobalamin Vitamin B Complex Micronutrients Growth Substances Physiological Effects of Drugs Hematinics |
ClinicalTrials.gov processed this record on September 27, 2016