Sunshine 2 Study for Women With Diabetes
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.
Timeline
- Start
- 2013-11-21
- Primary completion
- 2017-11-11
- Completion
- 2018-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 5000 iu | — |
| Subject | Cholecalciferol | Other / unclassified | 50000 iu | — |