Overview

Sunshine 2 Study for Women With Diabetes

Status:
Completed
Trial end date:
2018-08-31
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Loyola University
Collaborators:
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins