NCT00473200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
2.2 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

3.9 years

First QC Date

May 10, 2007

Last Update Submit

March 13, 2018

Conditions

Hyperhomocysteinemia

Keywords

hyperhomocysteinemiahomocysteineS-adenosylmethionineSAMeAsymmetric dimethylagrinine (ADMA)

Outcome Measures

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.

    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.

    6 weeks

Study Arms (2)

S-adenosylmethionine

ACTIVE COMPARATOR

S-adenosylmethionine

Dietary Supplement: S-adenosylmethionine

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: S-adenosylmethionine

Interventions

S-adenosylmethionineDIETARY_SUPPLEMENT

1200 mg daily

PlaceboS-adenosylmethionine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Hyperhomocysteinemia

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

MethionineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmino AcidsAmino Acids, Peptides, and ProteinsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Teodoro Bottiglieri, PhD

    Baylor Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

August 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

US(1)