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

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ClinicalTrials.gov Identifier: NCT00473200
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperhomocysteinemia Dietary Supplement: S-adenosylmethionine Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Oral S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine in Human Subjects
Study Start Date : August 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: S-adenosylmethionine
S-adenosylmethionine
Dietary Supplement: S-adenosylmethionine
1200 mg daily
Placebo Comparator: Placebo
Placebo
Dietary Supplement: S-adenosylmethionine
1200 mg daily



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473200


Locations
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Baylor Research Institute
National Institutes of Health (NIH)
Investigators
Study Director: Teodoro Bottiglieri, PhD Baylor Research Institute

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00473200     History of Changes
Other Study ID Numbers: 005-210
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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

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