Breast CancerNCT01817231
Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women
An observational study of Breast Cancer and Vitamin D Deficiency, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Vitamin D Deficiency
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Saudi Arabian women receiving care at King Fahd Women's clinic in Saudi Arabia during the summer of 2009.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Status and Breast Cancer in Saudi Arabian Women: Case Control Study
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.
- Conditions
- Breast Cancer, Vitamin D Deficiency
- Keywords
- breast cancer, vitamin D, 25 OH vitamin D
- Medical subject headings
- Breast Neoplasms, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer cases | breast cancer cases versus controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum vitamin D
assessed serum vitamin D in cases versus controls
Measured: cross-sectional from May 2009-August 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMay 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Thomson, University of Arizona
- Investigators
- Cynthia A Thomson, PhD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817231
- Sponsor's protocol ID
- SAVitaminD
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status and Breast Cancer in Saudi Arabian Women: Case Control Study
- ClinicalTrials.gov ID
- NCT01817231
- Acronym / sponsor ID
- SAVitaminD
- Conditions
- Breast Cancer, Vitamin D Deficiency
- Keywords
- breast cancer, vitamin D, 25 OH vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer cases | – | –breast cancer cases versus controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Saudi Arabian women receiving care at King Fahd Women's clinic in Saudi Arabia during the summer of 2009.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum vitamin D
Time frame: cross-sectional from May 2009-August 2009
assessed serum vitamin D in cases versus controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
- Derived from this study: PubMed 23697705Yousef 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia A Thomson, PhD study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Vitamin D Deficiency, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum vitamin D (time frame: cross-sectional from May 2009-August 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.