Sunshine 2 Study for Women With Diabetes

Loyola University

Status and phase: Completed; Phase 2

Conditions: Diabetes; Quality of Life; Depression

Treatments: Drug: Vitamin D3; Drug: Vitamin D3 comparator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01904032

1R01NR013906-01A1 (U.S. NIH Grant/Contract)

204197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 265 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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265 participants in 2 patient groups

Vitamin D3

Experimental group

Description:

50,000 international units (IUs) weekly Vitamin D3

Treatment:

Drug: Vitamin D3

Vitamin D3 comparator

Active Comparator group

Description:

5,000 international units (IUs) of a weekly Vitamin D3 comparator

Treatment:

Drug: Vitamin D3 comparator