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Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine

NCT ID: NCT00473200

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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

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Hyperhomocysteinemia

Keywords

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hyperhomocysteinemia homocysteine S-adenosylmethionine SAMe Asymmetric dimethylagrinine (ADMA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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S-adenosylmethionine

S-adenosylmethionine

Group Type ACTIVE_COMPARATOR

S-adenosylmethionine

Intervention Type DIETARY_SUPPLEMENT

1200 mg daily

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

S-adenosylmethionine

Intervention Type DIETARY_SUPPLEMENT

1200 mg daily

Interventions

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S-adenosylmethionine

1200 mg daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teodoro Bottiglieri, PhD

Role: STUDY_DIRECTOR

Baylor Research Institute

Locations

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Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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005-210

Identifier Type: -

Identifier Source: org_study_id