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

This study is currently recruiting participants.
Verified February 2013 by Baylor Research Institute
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00473200
First received: May 10, 2007
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Hyperhomocysteinemia
 Dietary Supplement: S-adenosylmethionine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Oral S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine in Human Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor Research Institute:

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. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S-adenosylmethionine
S-adenosylmethionine
 Dietary Supplement: S-adenosylmethionine
1200 mg daily
Placebo Comparator: Placebo
Placebo
 Dietary Supplement: S-adenosylmethionine
1200 mg daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473200

Contacts
Contact: Cara East, M.D. 214 820 2273
Contact: Merrielle Boatman 214 820 2273

Locations
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75204
Contact: Cara East, M.D.     214-820-2273     CaraE@baylorhealth.edu    
Contact: Merrille Boatman     214 820 2273        
Principal Investigator: Cara East, M.D.            
Sponsors and Collaborators
Baylor Research Institute
National Institutes of Health (NIH)
Investigators
Study Director: Teodoro Bottiglieri, PhD Baylor Research Institute
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00473200     History of Changes
Other Study ID Numbers: Baylor IRB #005-210
Study First Received: May 10, 2007
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
hyperhomocysteinemia
homocysteine
S-adenosylmethionine
SAMe
Asymmetric dimethylagrinine (ADMA)

Additional relevant MeSH terms:
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
 Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013