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

Sponsor

Baylor Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00473200

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperhomocysteinemia	Dietary Supplement: S-adenosylmethionine	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Effect of Oral S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine in Human Subjects

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: S-adenosylmethionine S-adenosylmethionine	Dietary Supplement: S-adenosylmethionine 1200 mg daily
Placebo Comparator: Placebo Placebo	Dietary Supplement: S-adenosylmethionine 1200 mg daily

Arm

Intervention/Treatment

Active Comparator: S-adenosylmethionine

S-adenosylmethionine

Dietary Supplement: S-adenosylmethionine

1200 mg daily

Placebo Comparator: Placebo

Placebo

Dietary Supplement: S-adenosylmethionine

1200 mg daily

Outcome Measures

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. [6 weeks]

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. [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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