Sunshine 2 Study for Women With Diabetes

The primary aim of this study is to determine the effect of vitamin D supplementation on
depressive symptoms, self-management, and systolic blood pressure compared to placebo. The
hypothesis is that women receiving vitamin D supplementation will report fewer depressive
symptoms, increased diabetes self- management mediated by depression improvement, and will
have a lower systolic blood pressure compared to those taking placebo at three and six months
follow-up.

The secondary aim is to explore the mechanistic effect of vitamin D supplementation on
inflammatory biomarkers and their association with depression. Here, the hypothesis is that
women receiving vitamin D supplementation will have a decrease in inflammatory biomarkers
which will be associated with fewer depressive symptoms compared to those taking placebo at
three and six months follow-up.

Inclusion Criteria:

- Women age 21 and older

- Objective evidence of depressive symptoms at the screening and baseline visits

- Diagnosis of type 2 diabetes currently being treated by a healthcare provider

- Blood vitamin D level less than 32 nanograms-per-deciliter (32 ng/dl)

Exclusion Criteria:

- Current alcohol or substance use disorder

- Any unstable or severe psychiatric disease including diagnoses of schizophrenia,
bipolar affective disorder, dementia, delirium, or other psychotic disorder

- Severe complications of diabetes, such as blindness and/or amputation

- Any malabsorption disorder, such as Crohn's disease and/or celiac sprue

- Elevated serum calcium level deemed significant by the Principal Investigator

- Use of 1,000 or more international units daily vitamin D 60 days before enrollment and
unwillingness to discontinue vitamin D supplementation 30 days before enrollment.

- Use of St. John's Wort and unwillingness to discontinue St. John's Wort three weeks
prior to enrollment.

- Participants who are pregnant, nursing, or planning to become pregnant during the
study.

- Baseline systolic blood pressure (SBP) greater than 160 millimeters of mercury (mmHG)
or diastolic blood pressure (DBP) greater than 100 mmHG.

- Other serious medical conditions (e.g., cancer, multiple sclerosis, etc.) deemed
clinically significant by the Principal Investigator