TonsillitisNCT00829972
Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls
An observational study of Tonsillitis, run by University of Chicago at 1 site in United States.
Trial summary
The investigators aim to evaluate the levels of serum Vitamin D in children having their tonsils removed and appropriate controls. The investigators hypothesize that children undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared to controls. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Tonsillitis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2009to 1 Nov 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children age 1-12 years undergoing surgery
Who may be able to join
- children age 1-12 undergoing adenotonsillectomy (active) or elective surgery such as hernia repair (control)
Who cannot join
- children on systemic steroids or multivitamins containing vitamin D
- control subjects with: a history of snoring, recurrent tonsillitis or score equal to or higher than 5 on the OSA questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to evaluate the levels of serum Vitamin D in children having their tonsils removed and appropriate controls. The investigators hypothesize that children undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.
- Conditions
- Tonsillitis
- Medical subject headings
- Tonsillitis
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 |
|---|---|---|
| 1 | children undergoing adenotonsillectomy | |
| 2 | children undergoing elective procedures other than adenotonsillectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study start1 Jan 2009
- Primary completion1 Sep 2009
- Study completion1 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuad M Baroody, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829972
- Sponsor's protocol ID
- 16687B
- Status last verified
- May 2023
- First submitted
- 26 Jan 2009
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls
- ClinicalTrials.gov ID
- NCT00829972
- Acronym / sponsor ID
- 16687B
- Conditions
- Tonsillitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Sep 2009 (actual)
- Study completion
- 1 Nov 2009 (actual)
- First posted
- 27 Jan 2009 (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 investigators aim to evaluate the levels of serum Vitamin D in children having their tonsils removed and appropriate controls. The investigators hypothesize that children undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –children undergoing adenotonsillectomy |
| 2 | – | –children undergoing elective procedures other than adenotonsillectomy |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children age 1-12 years undergoing surgery
Key inclusion criteria (1 listed)
- children age 1-12 undergoing adenotonsillectomy (active) or elective surgery such as hernia repair (control)
Key exclusion criteria (2 listed)
- children on systemic steroids or multivitamins containing vitamin D
- control subjects with: a history of snoring, recurrent tonsillitis or score equal to or higher than 5 on the OSA questionnaire.
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
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 6 May 2023.
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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.
Fuad M Baroody, MD principal investigator
University of Chicago
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 Tonsillitis, run by University of Chicago 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 1 inclusion and 2 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 6 May 2023. 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.
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 6 May 2023.