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Vitamin D for Improving Metabolic Control and Depressive Symptoms

Sponsor
Loyola University (Other)
Overall Status
Completed
CT.gov ID
NCT01185574
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
31
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin D supplementation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vitamin D for Improving Metabolic Control and Depressive Symptoms in Women With Diabetes; The Sunshine Study
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin D supplementation

The study medication (a capsule of 50,000 IU of vitamin D2) will be administered once a week for six months.

Dietary Supplement: Vitamin D supplementation
Vitamin D2 50,000 IU will be administered once a week for six months.
Other Names:
  • Drisdol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Metabolic control [6 months]

    Secondary Outcome Measures

    1. depressive symptoms [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loyola University Medical Center Maywood Illinois United States 60153

    Sponsors and Collaborators

    • Loyola University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sue Penckofer, Professor, Loyola University
    ClinicalTrials.gov Identifier:
    NCT01185574
    Other Study ID Numbers:
    • 201255
    First Posted:
    Aug 20, 2010
    Last Update Posted:
    Jul 11, 2013
    Last Verified:
    Jul 1, 2013
    Additional relevant MeSH terms:
    Depression
    Vitamin D

    Study Results

    No Results Posted as of Jul 11, 2013