Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Avitaminosis+9

+ Breast Diseases

+ Deficiency Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2009
See protocol details

Summary

Principal SponsorUniversity of Arizona
Last updated: March 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Arizona
Last updated: March 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AvitaminosisBreast DiseasesDeficiency DiseasesNeoplasmsNeoplasms by SiteNutrition DisordersNutritional and Metabolic DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMalnutritionBreast NeoplasmsVitamin D Deficiency

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Arizona

Tucson, United StatesOpen University of Arizona in Google Maps
CompletedOne Study Center