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

Hyperhomocysteinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473200
• Other study ID #: 005-210
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2007
• Last updated: March 13, 2018
• Start date: August 2009
• Est. completion date: July 2013

Study information

• Verified date: March 2018
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperhomocysteinemia

Intervention

Dietary Supplement:
• S-adenosylmethionine
1200 mg daily

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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