Sunshine 2 Study for Women With Diabetes

Depression Clinical Trial

Official title: Vitamin D Supplement to Women With Type 2 Diabetes

Status Completed

Clinical Trial 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.

Clinical Trial Description

The primary aim of this study is to determine the effect of vitamin D supplementation on depressive symptoms, self-management, and systolic blood pressure compared to placebo. The hypothesis is that women receiving vitamin D supplementation will report fewer depressive symptoms, increased diabetes self- management mediated by depression improvement, and will have a lower systolic blood pressure compared to those taking placebo at three and six months follow-up.

The secondary aim is to explore the mechanistic effect of vitamin D supplementation on inflammatory biomarkers and their association with depression. Here, the hypothesis is that women receiving vitamin D supplementation will have a decrease in inflammatory biomarkers which will be associated with fewer depressive symptoms compared to those taking placebo at three and six months follow-up. ;

Related Conditions & MeSH terms

• Depression
• Diabetes
• Diabetes Mellitus
• Quality of Life

• NCT number: NCT01904032
• Study type: Interventional
• Source: Loyola University
• Status: Completed
• Phase: Phase 2
• Start date: November 21, 2013
• Completion date: August 31, 2018