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Antioxidant Use in Diabetes to Reduce Oxidative Stress

NCT03056014 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-03-22

No results posted yet for this 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.

Conditions

  • Ameliorating Oxidative Stress in Type 1 Diabetes

Interventions

DRUG

N-acetyl cysteine

giving varying doses of NAC in order to determine which reduces oxidative stress.

DIETARY_SUPPLEMENT

omega 6 Fish oil ( PUFA)

giving varying doses of PUFA in order to determine which reduces oxidative stress.

DIETARY_SUPPLEMENT

Placebo

L-alanine placebo pill to determine if effect is supplement related or random effect.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-03-12
Completion
2020-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056014 on ClinicalTrials.gov