- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817231
Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women
Vitamin D Status and Breast Cancer in Saudi Arabian Women: Case Control Study
Study Overview
Status
Conditions
Detailed Description
Background: The role of vitamin D in breast cancer prevention is equivocal. Saudi Arabian women are thought to be at greater risk for vitamin D deficiency due to darker skin type and greater likelihood for reduced UVB radiation exposure. However, there is a lack of data regarding the vitamin D status of Saudi Arabian women and how this may relate to breast cancer risk.
Objective: The purpose of this research was to evaluate the association between circulating concentrations of 25(OH)D and breast cancer risk in Saudi Arabian women.
Design: A case-control study was conducted among 120 breast cancer cases and 120 controls. The study population was drawn from patients admitted to King Fahd Hospital in Jeddah, Saudi Arabia from June to August 2009. Participants completed questionnaires on diet and medical history and serum samples were collected from all women to measure circulating 25(OH)D concentrations.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85721
- University of Arizona
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Invasive breast cancer (cases) or healthy women (controls),
- receiving standard medical check-ups at the women's clinic
- Female,
- between the ages of 18 and 75 years
- BMI ≤ 40 kg/m2
- residence in Saudi Arabia for more than 5 years
- absence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease.
Exclusion Criteria:
receiving standard medical check-ups at the women's clinic
- Male,
- less than 18 or greater than 75 years of age
- BMI > 40 kg/m2
- Not a resident of Saudi Arabia for more than 5 years
- Presence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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breast cancer cases
breast cancer cases versus controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum vitamin D
Time Frame: cross-sectional from May 2009-August 2009
|
assessed serum vitamin D in cases versus controls
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cross-sectional from May 2009-August 2009
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Cynthia A Thomson, PhD, University of Arizona
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAVitaminD
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