Vitamin D DeficiencyNCT01118806
Vitamin D Levels in Residents in Medicine
An observational study of Vitamin D Deficiency, run by Meir Medical Center at 1 site in Israel.
Trial summary
the study aims to messure the vitamin D levels in medical staff in the hospital. The physicians in the course of their internship who work indoors and work many night shifts have limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at the same risk of liltle sun exposure. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 106 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Nov 2011
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: medical staff, interns doing night shifts. nursing staff.
Inclusion Criteria:medical staff Exclusion Criteria:pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Deficiency in Medical Residence in Israel
the study aims to messure the vitamin D levels in medical staff in the hospital. The physicians in the course of their internship who work indoors and work many night shifts have limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at the same risk of liltle sun exposure. The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,work load related to number of shifts in the physicien group and in nursing group the job percentile we also adress religion (clothing cover)as a factor.
Read the detailed description
The population in Israel is heterogeneous in the aspect of skin exposure to the sun. Women in the Moslem community with traditional long sleeve dress code whose sun exposure to the sun even in the summer months is limited.
The physicians in the course of their internship who work indoors and work many night shifts and nurses with their shift work have limited sun exposure in all seasons.
The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,number of shifts in the physicien group and in nursing group the job percentile religion (clothing cover).
The standard for measuring vitamin D status is 25(OH) D levels in the serum. The staff members from which blood will be drawn will be have an explanation about the aim of the study and will sign an informed consent.
- Conditions
- Vitamin D Deficiency
- Medical subject headings
- 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 |
|---|---|---|
| medical residents, vit d | vitamin | |
| levels of vitamin d | resident |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low vitamin D levels in direct relation to nomber of shifts/ job percentile
Measured: 1 year
low leves of vitamin D in direct relationship to nomber of shifts job percentile
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASSAF STEIN, Meir Medical Center
- Investigators
- Assaf Stein, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118806
- Sponsor's protocol ID
- 03
- Status last verified
- Nov 2011
- First submitted
- 5 May 2010
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Keith I. Ethamsylate and blood loss in total hip replacement. Anaesthesia. 1979 Jul-Aug;34(7):666-70. doi: 10.1111/j.1365-2044.1979.tb06368.x.
PubMed 517720Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462Millen AE, Bodnar LM. Vitamin D assessment in population-based studies: a review of the issues. Am J Clin Nutr. 2008 Apr;87(4):1102S-5S. doi: 10.1093/ajcn/87.4.1102S.
PubMed 18400742Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
PubMed 18400738McCarty CA. Sunlight exposure assessment: can we accurately assess vitamin D exposure from sunlight questionnaires? Am J Clin Nutr. 2008 Apr;87(4):1097S-101S. doi: 10.1093/ajcn/87.4.1097S.
PubMed 18400741
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency in Medical Residence in Israel
- ClinicalTrials.gov ID
- NCT01118806
- Acronym / sponsor ID
- 03
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 May 2010 (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.
the study aims to messure the vitamin D levels in medical staff in the hospital. The physicians in the course of their internship who work indoors and work many night shifts have limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at the same risk of liltle sun exposure. The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,work load related to number of shifts in the physicien group and in nursing group the job percentile we also adress religion (clothing cover)as a factor.
Detailed description
The population in Israel is heterogeneous in the aspect of skin exposure to the sun. Women in the Moslem community with traditional long sleeve dress code whose sun exposure to the sun even in the summer months is limited.
The physicians in the course of their internship who work indoors and work many night shifts and nurses with their shift work have limited sun exposure in all seasons.
The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,number of shifts in the physicien group and in nursing group the job percentile religion (clothing cover).
The standard for measuring vitamin D status is 25(OH) D levels in the serum. The staff members from which blood will be drawn will be have an explanation about the aim of the study and will sign an informed consent.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical residents, vit d | – | –vitamin |
| levels of vitamin d | – | –resident |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- medical staff, interns doing night shifts. nursing staff.
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
Low vitamin D levels in direct relation to nomber of shifts/ job percentile
Time frame: 1 year
low leves of vitamin D in direct relationship to nomber of shifts job percentile
Time frame: 1 year
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 23 Nov 2011.
- Background: PubMed 517720Keith I. Ethamsylate and blood loss in total hip replacement. Anaesthesia. 1979 Jul-Aug;34(7):666-70. doi: 10.1111/j.1365-2044.1979.tb06368.x.
- Results publication: PubMed 17634462Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Results publication: PubMed 18400742Millen AE, Bodnar LM. Vitamin D assessment in population-based studies: a review of the issues. Am J Clin Nutr. 2008 Apr;87(4):1102S-5S. doi: 10.1093/ajcn/87.4.1102S.
- Results publication: PubMed 18400738Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
- Results publication: PubMed 18400741McCarty CA. Sunlight exposure assessment: can we accurately assess vitamin D exposure from sunlight questionnaires? Am J Clin Nutr. 2008 Apr;87(4):1097S-101S. doi: 10.1093/ajcn/87.4.1097S.
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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.
Assaf Stein, MD principal investigator
Meir Medical Center
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 Vitamin D Deficiency, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Nov 2011. 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 Israel. 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?
Low vitamin D levels in direct relation to nomber of shifts/ job percentile (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01118806, which also lists 5 linked publications.
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 23 Nov 2011.