Assess Vitamin D Levels in Those With & Without Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00719615
First received: July 17, 2008
Last updated: March 15, 2010
Last verified: March 2010
Results First Received: January 27, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Thyroid Cancer

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Individuals (at University of Nebraska Medical Center)were selected from a thyroid tumor and cancer collaborative registry (TCCR), database & biospecimen bank, started March 2008. We achieved a sample size of 111 subjects with 24 patients with active thyroid cancer, 45 patients with thyroid cancer in remission and 42 patients with thyroid nodules.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Individuals who had agreed to participate in the TCCR and who had also given a blood sample were included in sequential order.

Reporting Groups
  Description
Thyroid Nodules No text entered.
Thyroid Cancer in Remission No text entered.
Active Thyroid Cancer No text entered.

Participant Flow:   Overall Study
    Thyroid Nodules     Thyroid Cancer in Remission     Active Thyroid Cancer  
STARTED     42     45     24  
COMPLETED     42     45     24  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Thyroid Nodules No text entered.
Thyroid Cancer in Remission No text entered.
Active Thyroid Cancer No text entered.
Total Total of all reporting groups

Baseline Measures
    Thyroid Nodules     Thyroid Cancer in Remission     Active Thyroid Cancer     Total  
Number of Participants  
[units: participants]
  42     45     24     111  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     40     44     22     106  
>=65 years     2     1     2     5  
Gender  
[units: participants]
       
Female     38     39     17     94  
Male     4     6     7     17  
Region of Enrollment  
[units: participants]
       
United States     42     45     24     111  



  Outcome Measures

1.  Primary:   Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups.   [ Time Frame: Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial limitations include that it was mostly done on Caucasian subjects; the controls were those with thyroid nodules not subjects without any thyroid disease; the sample size was small; & a small number of Vit D assays used different methods.  


Results Point of Contact:  
Name/Title: Whitney S Goldner, MD
Organization: University of Nebraska Medical Center
phone: 402-559-6205
e-mail: wgoldner@unmc.edu


Publications:


Responsible Party: Whitney Goldner, MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00719615     History of Changes
Other Study ID Numbers: 136-08-EP
Study First Received: July 17, 2008
Results First Received: January 27, 2010
Last Updated: March 15, 2010
Health Authority: United States: Institutional Review Board