Sunshine 2 Study for Women With Diabetes

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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