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

Phase 1

Completed

• Conditions: Hyperhomocysteinemia
• Interventions: Dietary Supplement: S-adenosylmethionine

• Registration Number: NCT00473200
• Lead Sponsor: Baylor Research Institute

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.

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 Timeline

• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-11
• Study First Posted: 2007-05-14
• Study Start: 2009-08
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	S-adenosylmethionine	Placebo
S-adenosylmethionine	S-adenosylmethionine	S-adenosylmethionine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States