Back to resultsEffect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine
Primary Purpose
Hyperhomocysteinemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
S-adenosylmethionine
Sponsored by
About this trial
This is an interventional basic science trial for Hyperhomocysteinemia focused on measuring hyperhomocysteinemia, homocysteine, S-adenosylmethionine, SAMe, Asymmetric dimethylagrinine (ADMA)
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and older
- Must have a serum homocysteine value greater than or equal to 14 μmol/L
- Stable weight 3 months prior to study participation
Exclusion Criteria:
- Subjects with a BMI greater than 35 or less than 18
- Currently taking B 100 or other high-dose B vitamin supplements within the past 12 months
- Taken methionine or SAMe supplements within the past 3 months
Sites / Locations
- Baylor University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
S-adenosylmethionine
Placebo
Arm Description
S-adenosylmethionine
Placebo
Outcomes
Primary Outcome Measures
To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine (tHcy) and asymmetric dimethylagrinine (ADMA) levels in subjects with mild to moderate hyperhomocysteinemia.
Secondary Outcome Measures
To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia.
Full Information
NCT ID
NCT00473200
First Posted
May 10, 2007
Last Updated
March 13, 2018
Sponsor
Baylor Research Institute
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00473200
Brief Title
Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine
Official Title
Effect of Oral S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine in Human Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (Hcy). More specifically, we will determine if chronic oral SAMe administration affects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia.
Detailed Description
The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (Hcy). More specifically, we will determine if chronic oral SAMe administration effects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia through the following specific aims:
Specific Aim 1 - To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine levels in subjects with mild to moderate hyperhomocysteinemia.
Specific Aim 2 - To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia.
Specific Aim 3 - To determine the effect of oral SAMe (1200 mg/day) on plasma levels pf asymmetric dimethylarginine (ADMA) in subjects with mild to moderate hyperhomocysteinemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhomocysteinemia
Keywords
hyperhomocysteinemia, homocysteine, S-adenosylmethionine, SAMe, Asymmetric dimethylagrinine (ADMA)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-adenosylmethionine
Arm Type
Active Comparator
Arm Description
S-adenosylmethionine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
S-adenosylmethionine
Intervention Description
1200 mg daily
Primary Outcome Measure Information:
Title
To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine (tHcy) and asymmetric dimethylagrinine (ADMA) levels in subjects with mild to moderate hyperhomocysteinemia.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age and older
Must have a serum homocysteine value greater than or equal to 14 μmol/L
Stable weight 3 months prior to study participation
Exclusion Criteria:
Subjects with a BMI greater than 35 or less than 18
Currently taking B 100 or other high-dose B vitamin supplements within the past 12 months
Taken methionine or SAMe supplements within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teodoro Bottiglieri, PhD
Organizational Affiliation
Baylor Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine
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