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Sunshine 2 Study for Women With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904032
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : September 27, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Sue Penckofer, Loyola University

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.

Condition or disease Intervention/treatment Phase
Diabetes Depression Quality of Life Drug: Vitamin D3 Drug: Vitamin D3 comparator Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplement to Women With Type 2 Diabetes
Actual Study Start Date : November 21, 2013
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: 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 Name: Cholecalciferol




Primary Outcome Measures :
  1. Center for Epidemiologic Studies Depression (CES-D) score comparing Baseline (Month 0) to Month 6 for the experimental cohort versus active comparator cohort [ Time Frame: After 6 months of treatment ]
    (1) Full Scale Name: Center for Epidemiologic Studies Depression (CES-D). (2) Definition: The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. (3) Construct Measured: Mood. (4) CES-D Score Range: Raw scores may range from 0 to 60, where higher scores indicate worse mood. (5) Change Calculation Details: Continuous/ordinal measure comparing mood from Baseline (month 0) to mood in month six for the experimental versus active comparator cohorts.


Secondary Outcome Measures :
  1. Problem Areas in Diabetes (PAIDS) score comparing Baseline (Month 0) to Month 6 for the experimental cohort versus active comparator cohort [ Time Frame: After 6 months of treatment ]
    (1) Full Scale Name: Problem Areas in Diabetes (PAIDS). (2) Definition: The PAIDS is a 20-item self-report scale that assesses diabetes burden and treatment. (3) Construct Measured: Distress. (4) PAIDS Score Range: Raw scores may range from 0 to 80, where higher scores indicate greater distress. (5) Change Calculation Details: Continuous measure comparing change in distress from Baseline (month 0) to month six for the experimental versus active comparator cohorts.

  2. Diabetes Self-Care Inventory score comparing Baseline (Month 0) to Month 6 for the experimental cohort versus active comparator cohort [ Time Frame: After 6 months of treatment ]
    (1) Full Scale Name: Diabetes Self-Care Inventory. (2) Definition: The Diabetes Self-Care Inventory is a 13-item self-report assessment of compliance with diabetes treatment for persons with type 2 diabetes. (3) Construct Measured: Self-Care. (4) Diabetes Self-Care Score Range: Raw scores may range from 13 to 65, where lower scores indicate poorer adherence to diabetes treatment and self-functioning. (5) Change Calculation Details: Continuous/ordinal measure comparing diabetes treatment compliance and self-care at Baseline (month 0) to compliance and self-care at month six for the experimental versus active comparator cohorts.

  3. Diabetes Self Efficacy Scale score comparing Baseline (Month 0) to Month 6 for the experimental cohort versus active comparator cohort [ Time Frame: Time Frame: After 6 months of treatment ]
    (1) Full Scale Name: Diabetes Self-Efficacy Scale. (2) Definition: The Diabetes Self-Efficacy Scale is an 8-item self-report scale assessing confidence in diabetes management. (3) Construct Measured: Diabetes management. (4) Diabetes Self-Efficacy Scale Score Range: Raw scores may range from 8 to 80, where lower scores indicate poorer diabetes management. (5) Change Calculation Details: continuous/ordinal measure comparing diabetes management from Baseline (month 0) to diabetes management in month six for the experimental versus active comparator cohorts.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904032


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Susan Penckofer, Ph.D., R.N. Loyola University Chicago Health Sciences Division
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Responsible Party: Sue Penckofer, Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01904032    
Other Study ID Numbers: 204197
1R01NR013906-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sue Penckofer, Loyola University:
Vitamin D
Diabetes
Self-Management
Depression
Women
Additional relevant MeSH terms:
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Diabetes Mellitus
Depression
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents