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NCT03056014 · ClinicalTrials.gov registry record · Early Phase 1
Antioxidant Use in Diabetes to Reduce Oxidative Stress
A Early Phase 1 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT03056014: Clinical Trial Early Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT03056014 is a Early Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056014, a Early Phase 1 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Dietary supplementation with antioxidant vitamins, such as Vitamin C and Vitamin E, reduces malformation rates in embryos of diabetic animals. However, human trials exploring the benefits of these antioxidant vitamins have produced unsatisfactory results in trials designed to alleviating diabetic retinopathy, cardiovascular disease, and preeclampsia in pregnancies. The investigators hypothesize that more potent, and better-targeted antioxidants, such as N-acetylcysteine (NAC) and Polyunsaturated Fatty Acids(PUFA), will be successful in preventing birth defects in the offspring of women with diabetes.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DRUG N-acetyl cysteine
- DIETARY_SUPPLEMENT omega 6 Fish oil ( PUFA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2020-03-12 |
| Phase | Early Phase 1 |
Why NCT03056014 stopped before completion
NCT03056014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03056014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03056014 about?
NCT03056014 is a clinical study titled "Antioxidant Use in Diabetes to Reduce Oxidative Stress". Dietary supplementation with antioxidant vitamins, such as Vitamin C and Vitamin E, reduces malformation rates in embryos of diabetic animals. However, human trials exploring the benefits of these antioxidant vitamins have produced unsatisfactory results in trials designed to alleviating diabetic re...
What is the current status of trial NCT03056014?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2018-11-01. Estimated completion is 2020-03-12.
What interventions are being tested in trial NCT03056014?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), N-acetyl cysteine (DRUG), omega 6 Fish oil ( PUFA) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03056014?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03056014's enrollment target sits among peer trials
8 1782nd of 2000 higher than 176 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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