Skip to main content
OpenTrials
Completed

NCT Number: NCT01185574

Vitamin D for Improving Metabolic Control and Depressive Symptoms

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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
  • 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.

Treatment and study plan

Vitamin D Supplementation

Dietary Supplement

Vitamin D2 50,000 IU will be administered once a week for six months.

Other names: Drisdol

Primary outcomes

  1. Metabolic control

    Time frame: 6 months

Secondary outcomes

  1. depressive symptoms

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2010
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.