Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels
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|ClinicalTrials.gov Identifier: NCT00284011|
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : January 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease||Dietary Supplement: SAMe Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||May 2006|
Active Comparator: SAMe
Two 400 mg pills.
Dietary Supplement: SAMe
800 mg dose daily for 4 weeks.
Placebo Comparator: Placebo
Two placebo pills (identical in appearance to SAMe).
2 placebo pills daily for 4 weeks.
- Homocysteine levels pre- and post- one month of SAMe administration. [ Time Frame: 1 Month ]
- An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests. [ Time Frame: 2 Weeks ]
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): NCT00284011
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Dietland Wahner-Roedler, M.D.||Mayo Clinic|