Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine
Effect of Oral S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine in Human Subjects
Sponsor: Baylor Research Institute
A PHASE1 clinical study on Hyperhomocysteinemia, this trial is completed. The trial is conducted by Baylor Research Institute and has accumulated 6 data snapshots since 2009. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
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Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE1
First recorded
Aug 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Baylor Research Institute
- National Institutes of Health (NIH)
For direct contact, visit the study record on ClinicalTrials.gov .