Effect of Oral Choline Supplementation on Postoperative Pain

This study has been terminated.
(PI left the institution.)
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00720343
First received: July 21, 2008
Last updated: March 23, 2016
Last verified: March 2016
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Postoperative Pain
Inflammation
Interventions: Drug: Choline
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Choline or Placebo

Oral choline or Placebo

Choline: Oral Choline or Placebo 20 grams before surgery


Participant Flow:   Overall Study
    Choline or Placebo  
STARTED     54  
COMPLETED     48 [1]
NOT COMPLETED     6  
Physician Decision                 3  
No data                 3  
[1] 3 removed by physician. 3 unable to be determined; Columbia will never have access to this data.



  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.
Data per arm is not available. Columbia will never have access to this data.

Reporting Groups
  Description
Choline or Placebo

Oral choline or Placebo

Choline: Oral Choline or Placebo 20 grams before surgery


Baseline Measures
    Choline or Placebo  
Number of Participants  
[units: participants]
  54  
Age, Customized  
[units: participants]
 
18 to 60 years     54  
Gender  
[units: participants]
 
Female     54  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     54  



  Outcome Measures

1.  Primary:   Prevalence of Pain   [ Time Frame: 24 hours after surgery ]

2.  Secondary:   Prevalence of Nausea   [ Time Frame: 24 hours after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Prevalence of High Blood Choline Concentration   [ Time Frame: 24 hours after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Prevalence of Opioid Use   [ Time Frame: 24 hours after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: CU PRS Administrator
Organization: Columbia University
phone: 212-342-1643
e-mail: crchelp@columbia.edu



Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00720343     History of Changes
Other Study ID Numbers: AAAC8413
1R21AT004708-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: July 21, 2008
Results First Received: March 23, 2016
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration