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Vitamin D for Improving Metabolic Control and Depressive Symptoms

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Loyola University

Status

Completed

Conditions

Depressive Symptoms
Diabetes

Treatments

Dietary Supplement: Vitamin D supplementation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
  1. 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Vitamin D supplementation
Experimental group
Description:
The study medication (a capsule of 50,000 IU of vitamin D2) will be administered once a week for six months.
Treatment:
Dietary Supplement: Vitamin D supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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