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NCT01379625 · ClinicalTrials.gov registry record · Phase 2
Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder
A Phase 2 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT01379625: Completed Phase 2 study, sponsored by Oregon Health and Science University.
NCT01379625 is a Phase 2 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01379625, a Phase 2 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Humans eat long-chain fat in their diet and use it for energy during exercise and during periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with exercise or illness. They can also develop a heart that does not function properly. These patients are tired and expend less energy than people who do not have a long-chain fatty acid oxidation disorder. However, they can use a supplement oil called medium chain triglyceride or MCT. This study will determine if a new experimental oil called Triheptanoin can decrease the muscle pain and increase the heart function and the amount of energy in patients with long-chain fatty acid oxidation disorders. Funding source - FDA's OOPD
Primary Outcome
Total energy expenditure will be measured by doubly labeled water and resting energy expenditure will be measured by indirect calorimetry at baseline and again after 4 months of either MCT or trihpetanoin treatment.
Interventions
- DRUG Triheptanoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01379625 record still lists
NCT01379625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which Triheptanoin is the first listed.
NCT01379625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01379625 about?
NCT01379625 is a clinical study titled "Study of Triheptanoin for Treatment of Long-Chain Fatty Acid Oxidation Disorder". Humans eat long-chain fat in their diet and use it for energy during exercise and during periods of fasting. Patients with long-chain fatty acid oxidation disorders cannot use dietary fat for energy. They sometimes develop muscle breakdown, and severe pain with exercise or illness. They can also dev...
What is the current status of trial NCT01379625?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2011-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01379625?
The interventions under investigation include: Triheptanoin (DRUG).
Who is sponsoring clinical trial NCT01379625?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01379625's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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