- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00284011
Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels
January 4, 2012 updated by: Dietlind Wahner-Roedler, Mayo Clinic
Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects
The purpose of this study is to determine if the oral intake of the dietary supplement SAMe increases blood homocysteine levels in healthy human subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
S-adenosyl-L-methionine (SAMe or AdoMet) is a commonly used nutritional supplement available in the United States since 1999.
SAMe is metabolized to homocysteine, a known cardiovascular risk factor.
No study has determined the effect exogenous SAMe administration has on the long-term levels of homocysteine in humans.
As a nutritional supplement, SAMe is not regulated by the Food and Drug Administration, despite being used to treat clinical diseases such as depression and osteoarthritis.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- Women and men age 18 - 65
- Able to understand and sign a consent form
Exclusion criteria:
- Smoking
- Pregnant or lactating
- Women actively trying to conceive
- Diagnosis of panic disorder or bipolar disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: SAMe
Two 400 mg pills.
|
800 mg dose daily for 4 weeks.
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Two placebo pills (identical in appearance to SAMe).
|
2 placebo pills daily for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Homocysteine levels pre- and post- one month of SAMe administration.
Time Frame: 1 Month
|
1 Month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests.
Time Frame: 2 Weeks
|
2 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dietland Wahner-Roedler, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (ACTUAL)
April 1, 2006
Study Completion (ACTUAL)
May 1, 2006
Study Registration Dates
First Submitted
January 30, 2006
First Submitted That Met QC Criteria
January 30, 2006
First Posted (ESTIMATE)
January 31, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
January 6, 2012
Last Update Submitted That Met QC Criteria
January 4, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 677-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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