Depressive Symptoms, Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin D supplementation
Vitamin D2 50,000 IU will be administered once a week for six months.
Sponsors
Loyola University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic control | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| depressive symptoms | 6 months |
Countries
United States
Outcome results
None listed