NCT01904032
Sunshine 2 Study for Women With Diabetes
PHASE2
COMPLETED
NCT01904032
INTERVENTIONAL
Vitamin D Supplement to Women With Type 2 Diabetes
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.
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
Diabetes
Depression
Quality of Life
- TREATMENT
-
- Type: DRUG
- Name: Vitamin D3
- Description: 50,000 international units (IUs) weekly Vitamin D3
- Arm Group Labels: Vitamin D3
-
- Type: DRUG
- Name: Vitamin D3 comparator
- Description: 5,000 international units (IUs) of a weekly Vitamin D3 comparator
- Arm Group Labels: Vitamin D3 comparator
- Loyola University