Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
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|ClinicalTrials.gov Identifier: NCT00694564|
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : September 13, 2013
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Pain||Drug: S-adenosyl methionine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||July 2012|
This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Drug: S-adenosyl methionine
S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
- Wong-Baker FACES Pain Rating Scale [ Time Frame: 0, 2 weeks, 1 month, 2 months ]We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).
- Safety [ Time Frame: 0, 2 weeks, 1 month, 2 month ]Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694564
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92103|
|Principal Investigator:||Jeannie Huang, MD, MPH||University of California, San Diego|