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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817231
• Other study ID #: SAVitaminD
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: March 22, 2013
• Start date: May 2009
• Est. completion date: August 2009

Study information

• Verified date: March 2013
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum vitamin D	assessed serum vitamin D in cases versus controls	cross-sectional from May 2009-August 2009	No