Trial Outcomes & Findings for Sunshine 2 Study for Women With Diabetes (NCT NCT01904032)
NCT ID: NCT01904032
Last Updated: 2022-04-26
Results Overview
The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
265 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2022-04-26
Participant Flow
Subjects were recruited from November 2013 through November 2017 (48 months)
Two-hundred sixty-five participants consented to participate in the study. Among these individuals, 136 (51.3%) were not randomized for failing to meet study inclusion criteria (134/136 or 98.5%) or because they withdrew consent prior to randomization (2/136 or 1.5%).
Participant milestones
| Measure |
Low Dose
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
|
Overall Study
COMPLETED
|
57
|
62
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Low Dose
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Sunshine 2 Study for Women With Diabetes
Baseline characteristics by cohort
| Measure |
Low Dose
n=64 Participants
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
n=65 Participants
50,000 international units (IUs) weekly Vitamin D3
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.14 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
50.02 years
STANDARD_DEVIATION 12.65 • n=7 Participants
|
50.58 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian or Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Arabic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
65 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Use of anti-depressants
No
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Use of anti-depressants
Yes
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Use of anti-depressants
Not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest level of education
8th grade or less
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest level of education
Some high school
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Highest level of education
High school graduate or GED
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Highest level of education
Some college or technical school
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Highest level of education
College graduate (bachelor's degree)
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Highest level of education
Graduate degree
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Annual Household Income
Less than $5,000
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Annual Household Income
$5,000 to $9,999
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Annual Household Income
$10,000 to $14,999
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Annual Household Income
$15,000 to $19,999
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Annual Household Income
$20,000 to $29,999
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Annual Household Income
$30,000 to $39,999
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Annual Household Income
$40,000 to $49,999
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Annual Household Income
$50,000 to $59,999
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Annual Household Income
$60,000 to $69,999
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Annual Household Income
$70,000 or more
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
CES-D
|
28.41 units on a scale
STANDARD_DEVIATION 8.39 • n=5 Participants
|
28.72 units on a scale
STANDARD_DEVIATION 8.50 • n=7 Participants
|
28.57 units on a scale
STANDARD_DEVIATION 8.41 • n=5 Participants
|
|
PHQ-9
|
11.91 units on a scale
STANDARD_DEVIATION 4.20 • n=5 Participants
|
11.74 units on a scale
STANDARD_DEVIATION 4.29 • n=7 Participants
|
11.82 units on a scale
STANDARD_DEVIATION 4.23 • n=5 Participants
|
|
Vitamin D3 Level
|
18.61 ng/mL
STANDARD_DEVIATION 6.66 • n=5 Participants
|
20.63 ng/mL
STANDARD_DEVIATION 6.60 • n=7 Participants
|
19.63 ng/mL
STANDARD_DEVIATION 6.68 • n=5 Participants
|
|
Parathyroid Hormone
|
49 ng/L
n=5 Participants
|
49 ng/L
n=7 Participants
|
49 ng/L
n=5 Participants
|
|
Calcium
|
9.4 mg/dL
n=5 Participants
|
9.4 mg/dL
n=7 Participants
|
9.4 mg/dL
n=5 Participants
|
|
Creatinine
|
0.74 mg/dL
STANDARD_DEVIATION 0.14 • n=5 Participants
|
0.75 mg/dL
STANDARD_DEVIATION 0.15 • n=7 Participants
|
0.75 mg/dL
STANDARD_DEVIATION 0.14 • n=5 Participants
|
|
Systolic blood pressure
|
128.41 mmHg
STANDARD_DEVIATION 16.40 • n=5 Participants
|
127.43 mmHg
STANDARD_DEVIATION 14.96 • n=7 Participants
|
127.91 mmHg
STANDARD_DEVIATION 15.63 • n=5 Participants
|
|
Diastolic blood pressure
|
71.97 mmHg
STANDARD_DEVIATION 10.64 • n=5 Participants
|
70.94 mmHg
STANDARD_DEVIATION 8.75 • n=7 Participants
|
71.45 mmHg
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Body mass index
|
39.10 kg/m^2
STANDARD_DEVIATION 8.28 • n=5 Participants
|
37.65 kg/m^2
STANDARD_DEVIATION 7.71 • n=7 Participants
|
38.37 kg/m^2
STANDARD_DEVIATION 8.00 • n=5 Participants
|
|
HBA1C
|
7.86 percentage of hemoglobin
STANDARD_DEVIATION 1.97 • n=5 Participants
|
7.68 percentage of hemoglobin
STANDARD_DEVIATION 1.69 • n=7 Participants
|
7.77 percentage of hemoglobin
STANDARD_DEVIATION 1.83 • n=5 Participants
|
|
Fasting glucose
|
170.47 mg/dL
STANDARD_DEVIATION 68.63 • n=5 Participants
|
152.52 mg/dL
STANDARD_DEVIATION 48.76 • n=7 Participants
|
161.43 mg/dL
STANDARD_DEVIATION 59.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The analysis population includes all women randomized to low dose or high dose therapy and completed the month 6 CES-D assessment.
The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score.
Outcome measures
| Measure |
Low Dose
n=57 Participants
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
n=62 Participants
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
|
-13.2982 units on a scale
Standard Deviation 10.2312
|
-12.5000 units on a scale
Standard Deviation 12.0065
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The analysis population includes all women randomized to low dose or high dose therapy and completed the month 6 PAID assessment.
The Problem Areas in Diabetes (PAIDS) score is a self-report questionnaire that assesses diabetes burden and treatment. Scores range from 0 to 100, where higher scores indicate greater distress. For each participant, her baseline PAID score is subtracted from her month 6 PAID score to create a PAID change score.
Outcome measures
| Measure |
Low Dose
n=57 Participants
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
n=62 Participants
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
|
-13.2237 score on a scale
Standard Deviation 17.6238
|
-13.2661 score on a scale
Standard Deviation 21.8782
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The analysis population includes all women randomized to low dose or high dose therapy and completed the in-person month 6 study visit.
Systolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline systolic blood pressure is subtracted from her month 6 systolic blood pressure to create a systolic blood pressure change score.
Outcome measures
| Measure |
Low Dose
n=57 Participants
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
n=62 Participants
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
|
-2.1579 mmHg
Standard Deviation 17.6491
|
-1.6613 mmHg
Standard Deviation 16.6821
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The analysis population includes all women randomized to low dose or high dose therapy and completed the in-person month 6 study visit.
Diastolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline diastolic blood pressure is subtracted from her month 6 diastolic blood pressure to create a diastolic blood pressure change score.
Outcome measures
| Measure |
Low Dose
n=57 Participants
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
n=62 Participants
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
|
-0.7544 mmHg
Standard Deviation 10.6692
|
0.7581 mmHg
Standard Deviation 9.6609
|
Adverse Events
Low Dose
Serious events: 5 serious events
Other events: 55 other events
Deaths: 0 deaths
High Dose
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose
n=64 participants at risk
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
n=65 participants at risk
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Nervous system disorders
Right sided weakness
|
0.00%
0/64 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
Nervous system disorders
Stroke
|
0.00%
0/64 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
Nervous system disorders
Acoustic neuroma
|
0.00%
0/64 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
Gastrointestinal disorders
Severe abdominal pain
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/64 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/64 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
Musculoskeletal and connective tissue disorders
Left tibia fracture
|
0.00%
0/64 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
Surgical and medical procedures
Laparoscopic cholecystectomy
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
0.00%
0/65 • Adverse event data were collected for seven months
|
|
Musculoskeletal and connective tissue disorders
Hiatal Hernia
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
0.00%
0/65 • Adverse event data were collected for seven months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Diagnosis
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
0.00%
0/65 • Adverse event data were collected for seven months
|
|
Musculoskeletal and connective tissue disorders
Right total knee replacement
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
0.00%
0/65 • Adverse event data were collected for seven months
|
Other adverse events
| Measure |
Low Dose
n=64 participants at risk
5,000 international units (IUs) of a weekly Vitamin D3 comparator
|
High Dose
n=65 participants at risk
50,000 international units (IUs) weekly Vitamin D3
|
|---|---|---|
|
Infections and infestations
Infection
|
25.0%
16/64 • Number of events 25 • Adverse event data were collected for seven months
|
18.5%
12/65 • Number of events 17 • Adverse event data were collected for seven months
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
26.6%
17/64 • Number of events 24 • Adverse event data were collected for seven months
|
16.9%
11/65 • Number of events 14 • Adverse event data were collected for seven months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
12.3%
8/65 • Number of events 8 • Adverse event data were collected for seven months
|
|
General disorders
Generalized Pain
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
6.2%
4/65 • Number of events 4 • Adverse event data were collected for seven months
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.9%
7/64 • Number of events 8 • Adverse event data were collected for seven months
|
10.8%
7/65 • Number of events 10 • Adverse event data were collected for seven months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Symptoms
|
20.3%
13/64 • Number of events 15 • Adverse event data were collected for seven months
|
10.8%
7/65 • Number of events 7 • Adverse event data were collected for seven months
|
|
General disorders
Dizziness
|
10.9%
7/64 • Number of events 9 • Adverse event data were collected for seven months
|
4.6%
3/65 • Number of events 7 • Adverse event data were collected for seven months
|
|
Renal and urinary disorders
Abnormal Kidney Function
|
6.2%
4/64 • Number of events 8 • Adverse event data were collected for seven months
|
4.6%
3/65 • Number of events 9 • Adverse event data were collected for seven months
|
|
Metabolism and nutrition disorders
Elevated Glucose
|
7.8%
5/64 • Number of events 6 • Adverse event data were collected for seven months
|
4.6%
3/65 • Number of events 3 • Adverse event data were collected for seven months
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/64 • Number of events 4 • Adverse event data were collected for seven months
|
6.2%
4/65 • Number of events 5 • Adverse event data were collected for seven months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
4/64 • Number of events 5 • Adverse event data were collected for seven months
|
10.8%
7/65 • Number of events 7 • Adverse event data were collected for seven months
|
|
General disorders
Nausea
|
6.2%
4/64 • Number of events 5 • Adverse event data were collected for seven months
|
16.9%
11/65 • Number of events 17 • Adverse event data were collected for seven months
|
|
Infections and infestations
Influenza
|
0.00%
0/64 • Adverse event data were collected for seven months
|
7.7%
5/65 • Number of events 5 • Adverse event data were collected for seven months
|
|
General disorders
Headache
|
10.9%
7/64 • Number of events 7 • Adverse event data were collected for seven months
|
10.8%
7/65 • Number of events 7 • Adverse event data were collected for seven months
|
|
Surgical and medical procedures
Routine Surgery
|
10.9%
7/64 • Number of events 9 • Adverse event data were collected for seven months
|
4.6%
3/65 • Number of events 3 • Adverse event data were collected for seven months
|
|
Psychiatric disorders
Worsening Mood
|
26.6%
17/64 • Number of events 17 • Adverse event data were collected for seven months
|
29.2%
19/65 • Number of events 19 • Adverse event data were collected for seven months
|
|
Metabolism and nutrition disorders
Worsening Diabetes
|
6.2%
4/64 • Number of events 5 • Adverse event data were collected for seven months
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for seven months
|
|
General disorders
Muscle Pain
|
4.7%
3/64 • Number of events 4 • Adverse event data were collected for seven months
|
6.2%
4/65 • Number of events 4 • Adverse event data were collected for seven months
|
|
Nervous system disorders
Numbness
|
6.2%
4/64 • Number of events 4 • Adverse event data were collected for seven months
|
9.2%
6/65 • Number of events 10 • Adverse event data were collected for seven months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
4/64 • Number of events 4 • Adverse event data were collected for seven months
|
3.1%
2/65 • Number of events 3 • Adverse event data were collected for seven months
|
|
General disorders
Lower Extremity Cramps
|
6.2%
4/64 • Number of events 4 • Adverse event data were collected for seven months
|
3.1%
2/65 • Number of events 2 • Adverse event data were collected for seven months
|
|
Reproductive system and breast disorders
Menstrual Symptoms
|
0.00%
0/64 • Adverse event data were collected for seven months
|
12.3%
8/65 • Number of events 8 • Adverse event data were collected for seven months
|
|
General disorders
Fatigue
|
7.8%
5/64 • Number of events 6 • Adverse event data were collected for seven months
|
12.3%
8/65 • Number of events 8 • Adverse event data were collected for seven months
|
|
General disorders
Generalized Soreness
|
4.7%
3/64 • Number of events 4 • Adverse event data were collected for seven months
|
6.2%
4/65 • Number of events 4 • Adverse event data were collected for seven months
|
|
General disorders
Swelling
|
1.6%
1/64 • Number of events 1 • Adverse event data were collected for seven months
|
7.7%
5/65 • Number of events 5 • Adverse event data were collected for seven months
|
|
General disorders
Fall
|
17.2%
11/64 • Number of events 17 • Adverse event data were collected for seven months
|
9.2%
6/65 • Number of events 6 • Adverse event data were collected for seven months
|
|
General disorders
Hypertension
|
9.4%
6/64 • Number of events 7 • Adverse event data were collected for seven months
|
9.2%
6/65 • Number of events 8 • Adverse event data were collected for seven months
|
Additional Information
Sue Penckofer, Ph.D., F.A.A.N.
Loyola University Chicago
Phone: 773-508-8949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place