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

B

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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