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

NCT ID: NCT01817231

Last Updated: 2013-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

breast cancer cases

breast cancer cases versus controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cynthia Thomson

Professor College of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cynthia A Thomson, PhD

Role: STUDY_CHAIR

University of Arizona

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arizona

Tucson, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23697705 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAVitaminD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitamin D Supplementation in Breast Cancer Patients
NCT06596122 NOT_YET_RECRUITING PHASE2
Vitamin D Supplementation in Breastfeeding Women
NCT01240265 COMPLETED PHASE2/PHASE3