Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls

This study is currently recruiting participants.

Verified by University of Chicago, January 2009

First Received: January 26, 2009 No Changes Posted

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00829972

Purpose

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.

Condition
Tonsillitis

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls

Resource links provided by NLM:

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by University of Chicago:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood samples

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 children undergoing adenotonsillectomy
2 children undergoing elective procedures other than adenotonsillectomy

Eligibility

Ages Eligible for Study:	1 Year to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children age 1-12 years undergoing surgery

Criteria

Inclusion Criteria:

children age 1-12 undergoing adenotonsillectomy (active) or elective surgery such as hernia repair (control)

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829972

Contacts

Contact: Rania Esteitie, MD

773-702-1502

resteiti@surgery.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Fuad M Baroody, MD

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Fuad M Baroody, MD

University of Chicago

More Information

No publications provided

Responsible Party:	Universikty of Chicago ( Fuad Baroody, MD )
Study ID Numbers:	16687B
Study First Received:	January 26, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00829972 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Vitamin D
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Vitamins
Tonsillitis
Stomatognathic Diseases
Pharyngeal Diseases

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Tonsillitis
Stomatognathic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on September 10, 2009