drugset
drugset / Trial / NCT03056014

Antioxidant Use in Diabetes to Reduce Oxidative Stress

NCT03056014 ↗

Phase 0 Terminated 8 enrolled University of Maryland, Baltimore
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2018-11-01
Primary completion
2020-03-12
Completion
2020-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 600 mg —
Subject N-acetylcysteine Small molecule 1200 mg —
Subject N-acetylcysteine Small molecule 1800 mg —

Indications

No indication recorded.