HyperhomocysteinemiaPhase 1NCT00473200
Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine
A Phase 1 study testing S-adenosylmethionine in people with Hyperhomocysteinemia, run by Baylor Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperhomocysteinemia
- What is being tested?
- S-adenosylmethionine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75204
About this study
Official title: Effect of Oral S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine in Human Subjects
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.
Read the 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.
- Conditions
- Hyperhomocysteinemia
- Being tested
- S-adenosylmethionine
- Keywords
- hyperhomocysteinemia, homocysteine, S-adenosylmethionine, SAMe, Asymmetric dimethylagrinine (ADMA)
- Medical subject headings
- Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-adenosylmethionineDietary supplement
1200 mg daily
| Study group | Role | What they receive |
|---|---|---|
| S-adenosylmethionine | Active comparator | S-adenosylmethionine Receives: Dietary Supplement: S-adenosylmethionine |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: S-adenosylmethionine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startAug 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhomocysteinemiaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Teodoro Bottiglieri, PhD, Study director, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473200
- Sponsor's protocol ID
- 005-210
- Status last verified
- Mar 2018
- First submitted
- 10 May 2007
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine in Human Subjects
- ClinicalTrials.gov ID
- NCT00473200
- Acronym / sponsor ID
- 005-210
- Conditions
- Hyperhomocysteinemia
- Keywords
- hyperhomocysteinemia, homocysteine, S-adenosylmethionine, SAMe, Asymmetric dimethylagrinine (ADMA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-adenosylmethionine | Active comparator | Dietary Supplement: S-adenosylmethionineS-adenosylmethionine |
| Placebo | Placebo comparator | Dietary Supplement: S-adenosylmethioninePlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-adenosylmethionine1200 mg daily | Dietary supplement | Placebo, S-adenosylmethionine |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teodoro Bottiglieri, PhD study director
Baylor Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-adenosylmethionine in people with Hyperhomocysteinemia, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.