NCT01185574

Vitamin D for Improving Metabolic Control and Depressive Symptoms

Official Title:

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

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.

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.

Disease(s) and\or Condition(s)

Depressive Symptoms

Diabetes

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DIETARY_SUPPLEMENT
    • Name: Vitamin D supplementation
    • Description: Vitamin D2 50,000 IU will be administered once a week for six months.
    • Arm Group Labels: Vitamin D supplementation
Sponsor
  • Loyola University