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NCT01192828 · ClinicalTrials.gov registry record · Phase 1
Oxidative Stress Markers In Inherited Homocystinuria And The Impact Of Taurine
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01192828: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT01192828 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192828, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Cystathionine beta-synthase deficiency is an inherited disease that results in elevation of a substance called homocysteine (Hcy) in blood and urine. Individuals with this disorder have a very high risk for developing blood clots and are at risk for developing eye and bone abnormalities. Current treatments are generally difficult to follow and can fail. Development of additional therapies has been limited by lack of understanding of how the disease works. The purpose of this study is to see if oxidative stress and inflammation are involved in the disease process and if short-term supplementation with taurine is an effective treatment. Funding source: FDA.
Primary Outcome
TBARS were measured in plasma via colorimetric absorbance. TBARS are a marker of oxidative stress. They are formed as a by-product of lipid (fat) oxidation. TBARS predominantly reflect the level of malondialdehyde (MDA) a substance that is formed from the breakdown of polyunsaturated fatty acids.
Interventions
- DRUG taurine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-01 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
What the finished NCT01192828 record still lists
NCT01192828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which taurine is the first listed.
NCT01192828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01192828 about?
NCT01192828 is a clinical study titled "Oxidative Stress Markers In Inherited Homocystinuria And The Impact Of Taurine". Cystathionine beta-synthase deficiency is an inherited disease that results in elevation of a substance called homocysteine (Hcy) in blood and urine. Individuals with this disorder have a very high risk for developing blood clots and are at risk for developing eye and bone abnormalities. Current tre...
What is the current status of trial NCT01192828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-01. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01192828?
The interventions under investigation include: taurine (DRUG).
Who is sponsoring clinical trial NCT01192828?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01192828's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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