Status:
COMPLETED
Sunshine 2 Study for Women With Diabetes
Lead Sponsor:
Loyola University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Conditions:
Diabetes
Depression
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
Brief 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...
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 w...
Eligibility Criteria
Inclusion
- Women age 21 and older
- Objective evidence of depressive symptoms at the screening and baseline visits
- Diagnosis of type 2 diabetes currently being treated by a healthcare provider
- Blood vitamin D level less than 32 nanograms-per-deciliter (32 ng/dl)
Exclusion
- Current alcohol or substance use disorder
- Any unstable or severe psychiatric disease including diagnoses of schizophrenia, bipolar affective disorder, dementia, delirium, or other psychotic disorder
- Severe complications of diabetes, such as blindness and/or amputation
- Any malabsorption disorder, such as Crohn's disease and/or celiac sprue
- Elevated serum calcium level deemed significant by the Principal Investigator
- Use of 1,000 or more international units daily vitamin D 60 days before enrollment and unwillingness to discontinue vitamin D supplementation 30 days before enrollment.
- Use of St. John's Wort and unwillingness to discontinue St. John's Wort three weeks prior to enrollment.
- Participants who are pregnant, nursing, or planning to become pregnant during the study.
- Baseline systolic blood pressure (SBP) greater than 160 millimeters of mercury (mmHG) or diastolic blood pressure (DBP) greater than 100 mmHG.
- Other serious medical conditions (e.g., cancer, multiple sclerosis, etc.) deemed clinically significant by the Principal Investigator
Key Trial Info
Start Date :
November 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT01904032
Start Date
November 21 2013
End Date
August 31 2018
Last Update
April 26 2022
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153