Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)
Status:
Terminated
Trial end date:
2018-07-12
Target enrollment:
Participant gender:
Summary
Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5
times higher in persons with diabetes than the general population. There is evidence that
cognitive decline significantly impacts the ability to self-manage diabetes. Strategies to
prevent cognitive decline in persons with diabetes has not been well studied. A recent study
reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and
Alzheimer's was doubled. Vitamin D receptors are located in the brain and deficiency of
vitamin D has been reported to negatively affect the development of brain. Therefore,
providing vitamin D supplementation to improve cognitive function is worthy of study. The
investigators propose a small, randomized controlled trial to determine the effects of
vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive
impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation
(50,000 IUs) or a matching comparator (5000 IUs) for a period of three months. The study aims
are to determine (1) the effect of vitamin D3 supplementation on cognitive function and (2)
the effect of vitamin D3 supplementation on diabetes self-management. A sample of persons
with type 2 diabetes (n=62), who have a subjective complaint of a cognitive dysfunction or
scoring at least one standard deviation below normal on a cognitive functioning screening
test, have vitamin D levels less 30 ng/ml, are not depressed (as this impacts cognitive
function), and do not have severe diabetes complication will be recruited. Participants will
be phone screened and complete two baseline visits prior to randomization. They will then
have phone call and follow-up visits to assess (1) cognitive function using standardized
tests to assess for executive function (2) serum measurements (HBA1c, fasting glucose,
vitamin D levels, and cardiometabolic profile) and (3) surveys to assess cognitive function
as well as self-management behaviors.
Phase:
Phase 2
Details
Lead Sponsor:
Loyola University
Collaborator:
University of Chicago
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins