SepsisNCT01080950
Vitamin D Zinc Fever
An observational study of Sepsis and Fever, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis. There are studies demonstrating an association between vitamin d deficiency and respiratory illnesses. Both zinc and vitamin d are associated with oxidative stress and inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients hospitalized with fever and or sepsis.
Who may be able to join
- age>18 years
Who cannot join
- CCT<90
- taking calcium
- hyper/hypoparathyroidism
- active malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin d and Zinc Levels in Patients With Fever
Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis.
There are studies demonstrating an association between vitamin d deficiency and respiratory illnesses.
Both zinc and vitamin d are associated with oxidative stress and inflammation.
Read the detailed description
Both vit. d and zinc share anti inflammatory and anti oxidative actions. vit. d deficiency is associated with an increase in serum levels of proinflammatory cytokines and decreased levels of anti inflammatory cytokines.
there are reports concerning the association of vit. d deficiency with infections.
- Keywords
- zinc, sepsis, fever, vitamin d
- Medical subject headings
- Sepsis, Fever
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 |
|---|---|---|
| fever zinc vit. d | patients with fever but without sepsis | |
| sepsis zinc vit. d | patients with sepsis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080950
- Sponsor's protocol ID
- vitamin d zinc and fever
- Status last verified
- Mar 2010
- First submitted
- 3 Mar 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin d and Zinc Levels in Patients With Fever
- ClinicalTrials.gov ID
- NCT01080950
- Acronym / sponsor ID
- vitamin d zinc and fever
- Keywords
- zinc, sepsis, fever, vitamin d
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 5 Mar 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.
Zinc and vitamin d deficiency are associated with a state of inflammation/atherosclerosis.
There are studies demonstrating an association between vitamin d deficiency and respiratory illnesses.
Both zinc and vitamin d are associated with oxidative stress and inflammation.
Detailed description
Both vit. d and zinc share anti inflammatory and anti oxidative actions. vit. d deficiency is associated with an increase in serum levels of proinflammatory cytokines and decreased levels of anti inflammatory cytokines.
there are reports concerning the association of vit. d deficiency with infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fever zinc vit. d | – | –patients with fever but without sepsis |
| sepsis zinc vit. d | – | –patients with sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized with fever and or sepsis.
Key inclusion criteria (1 listed)
- age>18 years
Key exclusion criteria (4 listed)
- CCT<90
- taking calcium
- hyper/hypoparathyroidism
- active malignancy.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2010.
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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.
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 Sepsis and Fever, run by Assaf-Harofeh 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?
The sponsor lists 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact renana shor, md (97289779240, renanashor@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 5 Mar 2010.