Sunshine 2 Study for Women With Diabetes
Condition: Diabetes; Depression; Quality of Life
MeSH terms: Diabetes Mellitus; Depression
Intervention: Vitamin D3; Vitamin D3 comparator
Intervention description: 50,000 international units (IUs) weekly Vitamin D3; 5,000 international units (IUs) of a weekly Vitamin D3 comparator
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to either 50,000 international units of weekly vitamin D3 or to 5,000 international units of weekly vitamin D3 using a 1:1 allocation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 265.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Vitamin D; Diabetes; Self-Management; Depression; Women

Summary:

      This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3
      supplementation on depressive symptoms, self-management, and blood pressure in approximately
      180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting
      adult women who are eligible to participate will be randomly assigned to either a weekly dose
      of 50,000 international units of vitamin D3 supplementation or a matching weekly active
      comparator of 5,000 international units of vitamin D3 for six months. Participants will
      complete approximately four in-person study visits and several telephone visits throughout
      the six month trial period, where the researchers will assess depressive symptoms, diabetes
      self-management, and systolic blood pressure.
    

Eligibility criteria:

        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