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NCT05720702 · ClinicalTrials.gov registry record · Early Phase 1
A Feasibility Trial of OCM Supplements for the Treatment of NAFLD
A Early Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 31
- Enrollment target
NCT05720702: Completed Early Phase 1 study, sponsored by Duke University.
NCT05720702 is a Early Phase 1 study that has completed, run by Duke University. The registered enrollment target is 31 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05720702, a Early Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the feasibility of a trial to test the effects of homocysteine (Hcy) lowering supplements in patients with NAFLD. NAFLD patients will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of approximately 12 to 13 weeks, participants will complete two in person visits and two phone visits to complete activities such as physical exam, fibroscan, blood draws, and questionnaires.
Primary Outcome
To minimize interindividual variability of fibroscan measurements, all of the fibroscan will be performed by a single, experienced operator using the same probe (M vs. XL) and technique for the paired measurements. The FibroScan-aspartate aminotransferase (FAST) score is a simple algorithm that can diagnose NASH using an elevated (≥ 4) NAFLD activity score (NAS) and significant fibrosis score (≥ 2).
Interventions
- DIETARY_SUPPLEMENT homocysteine (Hcy) lowering supplements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-06-30 |
| Est. Completion | 2024-08-23 |
| Phase | Early Phase 1 |
What the finished NCT05720702 record still lists
NCT05720702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which homocysteine (Hcy) lowering supplements is the first listed.
NCT05720702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05720702 about?
NCT05720702 is a clinical study titled "A Feasibility Trial of OCM Supplements for the Treatment of NAFLD". The purpose of the study is to assess the feasibility of a trial to test the effects of homocysteine (Hcy) lowering supplements in patients with NAFLD. NAFLD patients will be asked to take Hcy lowering supplements (Vitamin B12, Folate, Vitamin B6, and Betaine) daily for 12 weeks. Over the course of...
What is the current status of trial NCT05720702?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 31 participants. The study started on 2023-06-30. Estimated completion is 2024-08-23.
What interventions are being tested in trial NCT05720702?
The interventions under investigation include: homocysteine (Hcy) lowering supplements (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05720702?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05720702's enrollment target sits among peer trials
31 794th of 2000 higher than 1,194 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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