Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women

March 22, 2013 updated by: Cynthia Thomson, University of Arizona

Vitamin D Status and Breast Cancer in Saudi Arabian Women: Case Control Study

This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with breast cancer and 120 control women, to evalyate if vitamin D status is associated with breast cancer risk.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Saudi Arabian women receiving care at King Fahd Women's clinic in Saudi Arabia during the summer of 2009.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
breast cancer cases
breast cancer cases versus controls

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
cross-sectional from May 2009-August 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Study Chair: Cynthia A Thomson, PhD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 22, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAVitaminD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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