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CompletedNCT01817231Updated Mar 25, 2013

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

An observational study in Breast Cancer and Vitamin D Deficiency, sponsored by University of Arizona. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-25.

Sponsored by University of Arizona · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 75 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer
  • Vitamin D Deficiency

Keywords

  • breast cancer
  • vitamin D
  • 25 OH vitamin D
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 240 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
240 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • breast cancer cases

    breast cancer cases versus controls

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What researchers measure

Primary outcomes

  1. serum vitamin D

    assessed serum vitamin D in cases versus controls

    Time frame: cross-sectional from May 2009-August 2009

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Study locations

1 site
  • University of Arizona
    Tucson, Arizona 85721, United States
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References and documents

Publications

  • 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. PubMed 23697705 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01817231
Lead sponsor
University of Arizona
Responsible party
Cynthia Thomson (Professor College of Public Health, University of Arizona) — Principal investigator
First posted
Mar 25, 2013
Start date
May 2009
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Mar 25, 2013

Study contacts

Cynthia A Thomson, PhD
study chair · University of Arizona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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