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Completed

NCT Number: NCT00473200

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

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.

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Key information

Conditions

Hyperhomocysteinemia Amino Acid Metabolism, Inborn Errors Avitaminosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Genetic Diseases, Inborn Malabsorption Syndromes Malnutrition Metabolic Diseases Metabolism, Inborn Errors Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baylor University Medical Center

Dallas, Texas, 75204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-adenosylmethionine

Dietary Supplement

1200 mg daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 14, 2007
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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