Sunshine 2 Study for Women With Diabetes

NCT ID: NCT01904032

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-21
• Study Completion Date: 2018-08-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D3

50,000 international units (IUs) weekly Vitamin D3

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

50,000 international units (IUs) weekly Vitamin D3

Vitamin D3 comparator

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

Group Type: ACTIVE_COMPARATOR

Vitamin D3 comparator

Intervention Type: DRUG

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

Interventions

Vitamin D3

50,000 international units (IUs) weekly Vitamin D3

Intervention Type: DRUG

Vitamin D3 comparator

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

Intervention Type: DRUG

Other Intervention Names

Cholecalciferol; Cholecalciferol

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Sue

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Penckofer, Ph.D., R.N.

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago Health Sciences Division

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NR013906-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

204197

Identifier Type: -

Identifier Source: org_study_id