Plasma Homocysteine Distribution in the United States

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005483
• Other study ID #: 4970
• Secondary ID: R01HL052630
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: January 6, 2016
• Start date: December 1994
• Est. completion date: July 1999

Study information

• Verified date: January 2016
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1999
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hyperhomocysteinemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

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. — View 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. — View Citation