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Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00829972
First received: January 26, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by University of Chicago:

Biospecimen Retention:   Samples Without DNA

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

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013