drugset / Trial / NCT01904032

Sunshine 2 Study for Women With Diabetes

NCT01904032

RandomizedParallel-groupQuadruple-blindTreatment

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

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 5000 iu
Subject Cholecalciferol Other / unclassified 50000 iu