Vitamin D for Improving Metabolic Control and Depressive Symptoms

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185574
• Other study ID #: 201255
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: July 10, 2013
• Start date: October 2009
• Est. completion date: May 2012

Study information

• Verified date: July 2013
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Diabetes

Intervention

Dietary Supplement:
• Vitamin D supplementation
Vitamin D2 50,000 IU will be administered once a week for six months.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic control		6 months	No
Secondary	depressive symptoms		6 months	No