Trial Outcomes & Findings for Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D) (NCT NCT02416193)
NCT ID: NCT02416193
Last Updated: 2020-10-23
Results Overview
The the Letter-Number Sequencing Test (from the Wechsler Adult Intelligence Scale-III assessment) is an assessment of working memory. Scores on the assessment are standardized as scaled scores with a mean of 10 and standard deviation of 3 (μ = 10, SD = 3) using age adjusted normative data provided by Pearson assessments (https://www.pearsonassessments.com/). A scaled score indicates the number of standard deviations away from the mean. A scaled score of 10 is equal to the mean. Scaled scores below 10 indicate performance is lower than average, and scaled scores higher than 10 indicate performance is higher than average. Higher scaled scores indicate better performance.
TERMINATED
PHASE2
56 participants
13 weeks
2020-10-23
Participant Flow
Recruitment for this study took place at Loyola University Medical Center (Maywood, IL) between September 2015 and June 2018
Fifty-six participants consented to participate in the study. Among these individuals, 26 (46.43%) were not randomized and were excluded from continuing their participation in the study because the medical monitor determined they did not meet study inclusion criteria.
Participant milestones
| Measure |
Low Dose
5,000 IU cholecalciferol once weekly for three months
|
High Dose
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)
Baseline characteristics by cohort
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.62 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
55.80 years
STANDARD_DEVIATION 9.68 • n=7 Participants
|
55.71 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Years of education
|
14 years
n=5 Participants
|
14 years
n=7 Participants
|
14 years
n=5 Participants
|
|
Total vitamin D level
|
21 Nanograms per milliliter (ng/mL)
n=5 Participants
|
25 Nanograms per milliliter (ng/mL)
n=7 Participants
|
24 Nanograms per milliliter (ng/mL)
n=5 Participants
|
|
Serum vitamin D3 level
|
21 Nanograms per milliliter (ng/mL)
n=5 Participants
|
24 Nanograms per milliliter (ng/mL)
n=7 Participants
|
22 Nanograms per milliliter (ng/mL)
n=5 Participants
|
|
Body mass index
|
40.44 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 9.48 • n=5 Participants
|
34.20 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.05 • n=7 Participants
|
37.32 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 8.11 • n=5 Participants
|
|
Martial status
Currently married
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Martial status
Separated
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Martial status
Widowed
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Martial status
Divorced
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Martial status
Never married
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Season of first dose of the study drug
Fall
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Season of first dose of the study drug
Winter
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Season of first dose of the study drug
Spring
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Season of first dose of the study drug
Summer
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Systolic blood pressure
|
134.73 Millimeters of mercury (mmHg)
STANDARD_DEVIATION 16.33 • n=5 Participants
|
131.13 Millimeters of mercury (mmHg)
STANDARD_DEVIATION 16.95 • n=7 Participants
|
132.93 Millimeters of mercury (mmHg)
STANDARD_DEVIATION 16.45 • n=5 Participants
|
|
Diastolic blood pressure
|
73.47 Millimeters of mercury (mmHg)
STANDARD_DEVIATION 10.99 • n=5 Participants
|
72.93 Millimeters of mercury (mmHg)
STANDARD_DEVIATION 10.79 • n=7 Participants
|
73.20 Millimeters of mercury (mmHg)
STANDARD_DEVIATION 10.70 • n=5 Participants
|
|
Heart rate
|
73.27 Beats per minute (BPM)
STANDARD_DEVIATION 12.67 • n=5 Participants
|
76.00 Beats per minute (BPM)
STANDARD_DEVIATION 12.86 • n=7 Participants
|
74.63 Beats per minute (BPM)
STANDARD_DEVIATION 12.62 • n=5 Participants
|
|
HbA1c
|
7.10 mmol/mol
n=5 Participants
|
7.20 mmol/mol
n=7 Participants
|
7.15 mmol/mol
n=5 Participants
|
|
Glucose
|
120 Millimoles per liter (mmol/L)
n=5 Participants
|
142 Millimoles per liter (mmol/L)
n=7 Participants
|
134 Millimoles per liter (mmol/L)
n=5 Participants
|
|
Calcium
|
9.40 milligrams per deciliter (mg/dL)
n=5 Participants
|
9.60 milligrams per deciliter (mg/dL)
n=7 Participants
|
9.50 milligrams per deciliter (mg/dL)
n=5 Participants
|
|
Creatinine
|
0.74 milligrams per deciliter (mg/dL)
n=5 Participants
|
0.83 milligrams per deciliter (mg/dL)
n=7 Participants
|
0.79 milligrams per deciliter (mg/dL)
n=5 Participants
|
|
Activity level
Insufficiently active
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Activity level
Moderately active
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Activity level
Sufficiently active
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
WRAT-IV Reading Score
|
-1.00 units on a scale
n=5 Participants
|
-0.93 units on a scale
n=7 Participants
|
-0.97 units on a scale
n=5 Participants
|
|
Patient Health Questionnaire-9
|
2 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
3 units on a scale
n=5 Participants
|
|
CES-D Score
|
7.13 units on a scale
STANDARD_DEVIATION 3.46 • n=5 Participants
|
9.73 units on a scale
STANDARD_DEVIATION 4.80 • n=7 Participants
|
8.43 units on a scale
STANDARD_DEVIATION 4.32 • n=5 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.
The the Letter-Number Sequencing Test (from the Wechsler Adult Intelligence Scale-III assessment) is an assessment of working memory. Scores on the assessment are standardized as scaled scores with a mean of 10 and standard deviation of 3 (μ = 10, SD = 3) using age adjusted normative data provided by Pearson assessments (https://www.pearsonassessments.com/). A scaled score indicates the number of standard deviations away from the mean. A scaled score of 10 is equal to the mean. Scaled scores below 10 indicate performance is lower than average, and scaled scores higher than 10 indicate performance is higher than average. Higher scaled scores indicate better performance.
Outcome measures
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Letter-Number Sequencing
|
9.13 units on a scale
Standard Deviation 2.53
|
9.00 units on a scale
Standard Deviation 1.87
|
PRIMARY outcome
Timeframe: 13 WeeksPopulation: The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.
The Controlled Oral Word Association Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.
Outcome measures
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Controlled Oral Word Association Test
|
-0.35 units on a scale
Standard Deviation 1.10
|
-0.37 units on a scale
Standard Deviation 0.93
|
PRIMARY outcome
Timeframe: 13 WeeksPopulation: The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.
The Stroop Interference Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.
Outcome measures
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Stroop Interference Test
|
-0.15 units on a scale
Standard Deviation 0.88
|
-0.30 units on a scale
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: 13 WeeksPopulation: The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.
The Symbol-Digit Modality Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.
Outcome measures
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Symbol-Digit Modality Test
|
0.12 units on a scale
Standard Deviation 0.82
|
0.05 units on a scale
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: 13 WeeksPopulation: The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.
The Trail Making Test Part B is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.
Outcome measures
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Trail Making Test Part B
|
0.01 units on a scale
Standard Deviation 0.85
|
-0.10 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.
The Hopkins Verbal Learning Total Recall Test is an assessment of memory. Scores are standardized as T-scores (μ = 50, SD = 10) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. T-scores below 50 indicate performance is lower than average, and T-scores above 50 indicate performance is higher than average. Higher T-scores indicate better performance.
Outcome measures
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Hopkins Verbal Learning Total Recall Test
|
38.07 units on a scale
Standard Deviation 8.92
|
39.57 units on a scale
Standard Deviation 11.50
|
SECONDARY outcome
Timeframe: 13 WeeksPopulation: The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.
The Semantic Fluency Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.
Outcome measures
| Measure |
Low Dose
n=15 Participants
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 Participants
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Semantic Fluency Test
|
0.41 units on a scale
Standard Deviation 1.46
|
-0.36 units on a scale
Standard Deviation 0.95
|
Adverse Events
Low Dose
High Dose
Serious adverse events
| Measure |
Low Dose
n=15 participants at risk
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 participants at risk
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
Other adverse events
| Measure |
Low Dose
n=15 participants at risk
5,000 IU cholecalciferol once weekly for three months
|
High Dose
n=15 participants at risk
50,000 IU cholecalciferol once weekly for three months
|
|---|---|---|
|
Infections and infestations
Cold virus
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected for 20 weeks
|
|
Reproductive system and breast disorders
Short menstrual period
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/11 • Adverse event data were collected for 20 weeks
|
|
Reproductive system and breast disorders
Menstrual cramps
|
0.00%
0/14 • Adverse event data were collected for 20 weeks
|
9.1%
1/11 • Number of events 2 • Adverse event data were collected for 20 weeks
|
|
General disorders
Arm pain
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
General disorders
Toothache
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
General disorders
Nausea
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Eye disorders
Cataracts
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Endocrine disorders
Hypercalcemia
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
Renal and urinary disorders
Hemorrhoids
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
General disorders
Poor appetite
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
Gastrointestinal disorders
Dark stools
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
Infections and infestations
Sinus infection
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
Infections and infestations
Strep throat
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
General disorders
Sore throat
|
6.7%
1/15 • Number of events 3 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Nervous system disorders
Fall
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
General disorders
Tiredness
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
General disorders
Muscle aches
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
Endocrine disorders
Goiter
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
General disorders
Arhritis
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
General disorders
Foot pain
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
General disorders
Restlessness
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
|
General disorders
Shoulder pain
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Skin and subcutaneous tissue disorders
Knee cyst
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
General disorders
Leg cramps
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Social circumstances
Motor vehicle accident
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 20 weeks
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
|
Cardiac disorders
Hypertension
|
0.00%
0/15 • Adverse event data were collected for 20 weeks
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected for 20 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place