Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 9/30/2018 |
| Start Date: | April 2015 |
| End Date: | July 12, 2018 |
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.
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.
Study Aims 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 (1). There is
evidence that cognitive decline significantly impacts the ability to self-manage diabetes
(2). 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 (3). Vitamin D receptors are located in the
brain, and deficiency of vitamin D has been reported to negatively affect the development of
brain and impact both growth factor signaling and neural activity (4, 5). Therefore,
providing vitamin D supplementation to improve cognitive function in persons with diabetes
who are at great risk for this comorbid condition is important. 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.
Primary Aim: To determine the effect of vitamin D3 supplementation on cognitive function for
persons with type 2 diabetes.
Primary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will
have improved cognitive function compared to those receiving the comparator (5000 IUs) at
three months.
Secondary Aim: To determine the effect of vitamin D3 supplementation on diabetes
self-management.
Secondary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will
have improved self-management compared to those receiving the comparator (5000 IUs) at three
months.
The importance of this study is several fold. Vitamin D supplementation is a low cost
intervention (6), it has minimal side effects (7), and it could have high impact for persons
with type 2 diabetes who suffer from cognitive impairment which can significantly affect
their diabetes self-management.
1.5 to 2.5 times higher in persons with diabetes than the general population (1). There is
evidence that cognitive decline significantly impacts the ability to self-manage diabetes
(2). 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 (3). Vitamin D receptors are located in the
brain, and deficiency of vitamin D has been reported to negatively affect the development of
brain and impact both growth factor signaling and neural activity (4, 5). Therefore,
providing vitamin D supplementation to improve cognitive function in persons with diabetes
who are at great risk for this comorbid condition is important. 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.
Primary Aim: To determine the effect of vitamin D3 supplementation on cognitive function for
persons with type 2 diabetes.
Primary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will
have improved cognitive function compared to those receiving the comparator (5000 IUs) at
three months.
Secondary Aim: To determine the effect of vitamin D3 supplementation on diabetes
self-management.
Secondary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will
have improved self-management compared to those receiving the comparator (5000 IUs) at three
months.
The importance of this study is several fold. Vitamin D supplementation is a low cost
intervention (6), it has minimal side effects (7), and it could have high impact for persons
with type 2 diabetes who suffer from cognitive impairment which can significantly affect
their diabetes self-management.
Inclusion Criteria:
- Women and men aged 18 to 75 years
- Have type 2 diabetes
- Having a subjective complaint of a cognitive dysfunction or scoring at least one
standard deviation below normal on a cognitive functioning screening test
- Vitamin D level as measured by 25-hydroxyvitamin D (25-OH D) < 32 ng/mL
- Under the care of a healthcare provider
- Systolic blood pressure ≤160 and diastolic blood pressure ≤100
Exclusion Criteria:
- Persons with malabsorption problems (e.g., crohn's disease)
- Hypercalcemia
- Supplementation other than a daily multivitamin
- Severe complications of diabetes (i.e., amputation, blindness, and dialysis)
- Concomitant use of steroids
- GFR < 60
- Creatinine > 1.2
- Significant depressive symptoms
- Having a history of bipolar depression, psychotic disorders, loss of consciousness
greater than 5 minutes, or a current alcohol or substance use disorder
- Other serious medical conditions deemed significant by the PI or medical monitor
- Concomitant use of cholinesterase inhibitors
- Concomitant use of anxiolytics, kava kava, St. John's Wort, or Ginkgo Biloba
- Pregnancy
- HbA1c >13%
We found this trial at
1
site
2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Mary A Byrn, Ph.D., R.N.
Phone: 773-508-3249
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