Sunshine 2 Study for Women With Diabetes

NCT01904032 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2041971R01NR013906-01A1
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Depression; Quality of Life

Keywords

Vitamin D; Diabetes; Self-Management; Depression; Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

  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

  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

  Baseline and 6 months

Study Arms (2)

Vitamin D3

EXPERIMENTAL

50,000 international units (IUs) weekly Vitamin D3

Drug: Vitamin D3

Vitamin D3 comparator

ACTIVE COMPARATOR

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

Drug: Vitamin D3 comparator

Interventions

Vitamin D3 DRUG

50,000 international units (IUs) weekly Vitamin D3

Also known as: Cholecalciferol

Vitamin D3

Vitamin D3 comparator DRUG

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

Also known as: Cholecalciferol

Vitamin D3 comparator

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

There are no limitations or caveats to report

Results Point of Contact

• Title: Sue Penckofer, Ph.D., F.A.A.N.
• Organization: Loyola University Chicago

spencko@luc.edu

773-508-8949

Study Officials

• Susan Penckofer, Ph.D., R.N.

  Loyola University Chicago Health Sciences Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomized to either 50,000 international units of weekly vitamin D3 or to 5,000 international units of weekly vitamin D3 using a 1:1 allocation

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: November 21, 2013
• Primary Completion: November 11, 2017
• Study Completion: August 31, 2018
• Last Updated: April 26, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)