Status:
COMPLETED
Vitamin D for Improving Metabolic Control and Depressive Symptoms
Lead Sponsor:
Loyola University
Conditions:
Depressive Symptoms
Diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 Vi...
Eligibility Criteria
Inclusion
- Women aged 18 and older
- medically stable type 2 diabetes with HBA1c \<9%.
- 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
- vitamin D levels of 32 ng/dl or greater
- malabsorption problems (e.g., crohn's disease, celiac sprue)
- hypercalcemia-level greater than 10.5 mg/dl
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01185574
Start Date
October 1 2009
End Date
May 1 2012
Last Update
July 11 2013
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153