Sunshine 2 Study for Women With Diabetes

Overview

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 Title of Study: “Vitamin D Supplement to Women With Type 2 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 11, 2017

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Vitamin D3
    • 50,000 international units (IUs) weekly Vitamin D3
  • Active Comparator: Vitamin D3 comparator
    • 5,000 international units (IUs) of a weekly Vitamin D3 comparator

Clinical Trial Outcome Measures

Primary Measures

  • Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
    • Time Frame: Baseline and 6 months
    • The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score.

Secondary Measures

  • Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
    • Time Frame: Baseline and 6 months
    • The Problem Areas in Diabetes (PAIDS) score is a self-report questionnaire that assesses diabetes burden and treatment. Scores range from 0 to 100, where higher scores indicate greater distress. For each participant, her baseline PAID score is subtracted from her month 6 PAID score to create a PAID change score.
  • Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
    • Time Frame: Baseline and 6 months
    • Systolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline systolic blood pressure is subtracted from her month 6 systolic blood pressure to create a systolic blood pressure change score.
  • Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
    • Time Frame: Baseline and 6 months
    • Diastolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline diastolic blood pressure is subtracted from her month 6 diastolic blood pressure to create a diastolic blood pressure change score.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Loyola University
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sue, Professor – Loyola University
  • Overall Official(s)
    • Susan Penckofer, Ph.D., R.N., Principal Investigator, Loyola University Chicago Health Sciences Division

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