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

Completed

• Conditions: Breast Cancer; Vitamin D Deficiency

• Registration Number: NCT01817231
• Lead Sponsor: University of Arizona

Brief Summary

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.

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 Timeline

• Study Start: 2009-05
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2013-03
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-22
• Last Update Submitted: 2013-03-22
• Study First Posted: 2013-03-25
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum vitamin D	cross-sectional from May 2009-August 2009	assessed serum vitamin D in cases versus controls

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States