Cognitive Decline Clinical Trial
Official title:
The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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