Sunshine 2 Study for Women With Diabetes

Vitamin D Supplement to Women With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Diabetes
• Intervention / Treatment: Drug: Vitamin D3; Drug: Vitamin D3 comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin D3; 50,000 international units (IUs) weekly Vitamin D3	Drug: Vitamin D3; 50,000 international units (IUs) weekly Vitamin D3; Other Names: Cholecalciferol
ACTIVE_COMPARATOR: Vitamin D3 comparator; 5,000 international units (IUs) of a weekly Vitamin D3 comparator	Drug: Vitamin D3 comparator; 5,000 international units (IUs) of a weekly Vitamin D3 comparator; Other Names: Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort	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.	Baseline and 6 months
Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort	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.	Baseline and 6 months
Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort	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.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Loyola University
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Susan Penckofer, Ph.D., R.N., Loyola University Chicago Health Sciences Division

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2013
• Primary Completion (ACTUAL): November 11, 2017
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (ESTIMATE): July 22, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Diabetes; Vitamin D; Women; Self-Management
• Additional Relevant MeSH Terms: Behavioral Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Depression; Diabetes Mellitus; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 204197; 1R01NR013906-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No