NCT01904032

Sunshine 2 Study for Women With Diabetes

Vitamin D Supplement to Women With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes
• Depression
• Quality of Life

Interventions

Type	Name	Description
DRUG	Vitamin D3	50,000 international units (IUs) weekly Vitamin D3
DRUG	Vitamin D3 comparator	5,000 international units (IUs) of a weekly Vitamin D3 comparator

Timeline

• Start date: 2013-11-21
• Primary completion: 2017-11-11
• Completion: 2018-08-31
• First posted: 2013-07-22
• Last updated: 2022-04-26
• Results posted: 2022-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study