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

Baylor Scott and White Health (BSWH)

Status and phase: Completed; Phase 1

Conditions: Hyperhomocysteinemia

Treatments: Dietary Supplement: S-adenosylmethionine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00473200

005-210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

S-adenosylmethionine

Active Comparator group

Description:

S-adenosylmethionine

Treatment:

Dietary Supplement: S-adenosylmethionine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: S-adenosylmethionine