NCT00829972

Brief 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. The investigators also hypothesize that Vitamin D deficiency will correlate with indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

January 26, 2009

Last Update Submit

May 3, 2023

Conditions

Tonsillitis

Study Arms (2)

1

children undergoing adenotonsillectomy

2

children undergoing elective procedures other than adenotonsillectomy

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children age 1-12 years undergoing surgery

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Tonsillitis

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Fuad M Baroody, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

US(1)