Clinical trial NCT01817231: Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women
Official title: Vitamin D Status and Breast Cancer in Saudi Arabian Women: Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Vitamin D Deficiency
Keywords: breast cancer
vitamin D
25 OH vitamin D
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: serum vitamin D
timeFrame: cross-sectional from May 2009-August 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Cynthia A Thomson, PhD
role: STUDY_CHAIR
References:
citation: Yousef FM, Jacobs ET, Kang PT, Hakim IA, Going S, Yousef JM, Al-Raddadi RM, Kumosani TA, Thomson CA. Vitamin D status and breast cancer in Saudi Arabian women: case-control study. Am J Clin Nutr. 2013 Jul;98(1):105-10. doi: 10.3945/ajcn.112.054445. Epub 2013 May 22.