ClinicalTrials.gg
CompletedNCT00005483Updated Jan 8, 2016

Plasma Homocysteine Distribution in the United States

An observational study in Cardiovascular Diseases, Heart Diseases and Hyperhomocysteinemia, sponsored by Tufts University. Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-01-08.

Primary conditionHeart DiseasesRegistry: Cardiovascular DiseasesReclassifiedWhy we changed it
Registry
Cardiovascular Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Heart Diseases
Why
  1. The study's listed conditions name Heart Diseases, a narrower term within Cardiovascular Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Tufts University · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
01

Study 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.

Read the 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..

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Hyperhomocysteinemia

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03

In context

Heart Diseases Reclassified

2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.

Browse Heart Diseases studies →

Lead sponsor

Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Compared within Heart Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 10475885 ↗
  • 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. PubMed 10075334 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 1994 and a completion of Jul 1999. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2000
First posted
May 26, 2000
Start
Dec 1994
Completion
Jul 1999
Last update
Jan 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Jan 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00005483
Lead sponsor
Tufts University
First posted
May 26, 2000
Start date
Dec 1994
Completion
Jul 1999
Last update
Jan 8, 2016

Study contacts

Jacob Selhub
Tufts University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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