Vitamin D for Improving Metabolic Control and Depressive Symptoms

Vitamin D for Improving Metabolic Control and Depressive Symptoms in Women With Diabetes; The Sunshine Study

This study will examine whether weekly vitamin D supplementation in women with significant depressive symptoms and diabetes will exhibit improved mood and metabolic control. If supplementation with Vitamin D is beneficial, it will be a simple and cost-effective method for treatment. Women will be targeted since they have greater depression and worse metabolic control than men with diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes; Depressive Symptoms
• Intervention / Treatment: Dietary supplement: Vitamin D supplementation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged 18 and older
2. medically stable type 2 diabetes with HBA1c <9%.
3. significantly elevated depressive symptoms as measured by a score greater than or equal to 14 using the Center for Epidemiologic Studies Depression Tool (CES-D.

Exclusion Criteria:

1. vitamin D levels of 32 ng/dl or greater
2. malabsorption problems (e.g., crohn's disease, celiac sprue)
3. hypercalcemia-level greater than 10.5 mg/dl
4. Severe complications of diabetes (amputation, blindness, or renal problems) 5) Women with low thyroid function

6) active suicidal ideation, a history of bipolar depression, psychotic disorders, and current alcohol or substance disorders. Active treatment for depression (e.g., antidepressant therapy) will not be exclusion criteria 7) Any serious chronic illness that may impact on their health-related quality of life and treatment effect 8) Women who are pregnant 9) Women who have had bariatric surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D supplementation; The study medication (a capsule of 50,000 IU of vitamin D2) will be administered once a week for six months.	Dietary supplement: Vitamin D supplementation; Vitamin D2 50,000 IU will be administered once a week for six months.; Other Names: Drisdol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolic control	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
depressive symptoms	6 months

Collaborators and Investigators

• Sponsor: Loyola University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 201255