Vitamin D for Improving Metabolic Control and Depressive Symptoms

Not Applicable

Completed

• Conditions: Depressive Symptoms; Diabetes
• Interventions: Dietary Supplement: Vitamin D supplementation

• Registration Number: NCT01185574
• Lead Sponsor: Loyola University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-20
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D supplementation	Vitamin D supplementation	The study medication (a capsule of 50,000 IU of vitamin D2) will be administered once a week for six months.

Primary Outcome Measures

Name	Time	Method
Metabolic control	6 months

Secondary Outcome Measures

Name	Time	Method
depressive symptoms	6 months

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States