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N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

NCT00915200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2016-06-27

No results posted yet for this study

Summary

The study is designed to test if the combination of two potent antioxidant nutritional supplements, N-acetylcysteine and the milk thistle extract silibin, is capable of correcting the shedding of urine protein, the oxidative stress, and the inflammation in patients with type 2 diabetes mellitus and diabetic kidney disease.

Conditions

  • Diabetic Nephropathies
  • Proteinuria
  • Oxidative Stress

Interventions

DIETARY_SUPPLEMENT

N-acetylcysteine

600 mg orally twice daily for three months

DIETARY_SUPPLEMENT

silibin

480 mg orally twice daily for three months

DIETARY_SUPPLEMENT

high-dose silibin

960 mg orally twice daily for three months

DIETARY_SUPPLEMENT

N-acetylcysteine placebo

excipient orally twice daily for three months

DIETARY_SUPPLEMENT

silibin placebo

excipient orally twice daily for three months

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • VA Office of Research and Development

    collaborator FED

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Paolo Fanti, M.D. · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT00915200 on ClinicalTrials.gov