Plasma Homocysteine Distribution in the United States
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hyperhomocysteinemia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005483
First Posted
May 25, 2000
Last Updated
January 6, 2016
Sponsor
Tufts University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005483
Brief Title
Plasma Homocysteine Distribution in the United States
Study Type
Observational
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tufts University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To describe the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. To determine the extent to which hyperhomocysteinemia is associated with status of folate and vitamin B12. Finally, to describe the relationships between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and assess the importance of this risk factor as a cause of vascular disease among US adults. The study was renewed for one year to investigate normal homocysteine concentrations among children and to identify nutritional and non-nutritional determinants of total homocysteine concentrations in children.
Detailed Description
BACKGROUND:
Hyperhomocysteinemia, a condition of elevated plasma homocysteine concentrations resulting from impaired sulfur amino acid metabolism, may be a powerful risk factor for occlusive vascular disease. However, little is known about the distribution of hyperhomocysteinemia in the general population. Furthermore, inadequate nutritional status might be a strong determinant of hyperhomocysteinemia, but its importance at a population level (as measured by the prevalence of hyperhomocysteinemia associated with inadequate nutrition) has received little study. Finally, levels of homocysteine associated with elevated risk of vascular disease have not been clearly established.
DESIGN NARRATIVE:
Using previously collected plasma samples, studies were conducted on the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. Investigations were undertaken on the extent of the relationship of hyperhomocysteinemia to folate and vitamin B12. Finally, the relationships were described between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and the importance of this risk factor as a cause of vascular disease among US adults was assessed..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hyperhomocysteinemia
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Selhub
Organizational Affiliation
Tufts University
12. IPD Sharing Statement
Citations:
PubMed Identifier
10475885
Citation
Selhub J, Jacques PF, Rosenberg IH, Rogers G, Bowman BA, Gunter EW, Wright JD, Johnson CL. Serum total homocysteine concentrations in the third National Health and Nutrition Examination Survey (1991-1994): population reference ranges and contribution of vitamin status to high serum concentrations. Ann Intern Med. 1999 Sep 7;131(5):331-9. doi: 10.7326/0003-4819-131-5-199909070-00003.
Results Reference
background
PubMed Identifier
10075334
Citation
Jacques PF, Rosenberg IH, Rogers G, Selhub J, Bowman BA, Gunter EW, Wright JD, Johnson CL. Serum total homocysteine concentrations in adolescent and adult Americans: results from the third National Health and Nutrition Examination Survey. Am J Clin Nutr. 1999 Mar;69(3):482-9. doi: 10.1093/ajcn/69.3.482.
Results Reference
background
Learn more about this trial
Plasma Homocysteine Distribution in the United States
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