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N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

NCT01265563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2018-10-19

Study results available
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Summary

The study is done to find out whether the combined use of the nutritional supplements N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein and oxidative damage (damage to cells and organs often compared to fast aging) in patients with Type 2 Diabetes Mellitus (T2DM) and diabetic kidney disease.

Conditions

  • Diabetic Nephropathy
  • Proteinuria
  • Oxidative Stress

Interventions

DRUG

N-acetylcysteine placebo and silibin placebo

Dietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months

DRUG

N-acetylcysteine active and silibin placebo

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months

DRUG

N-acetylcysteine placebo and silibin active

Dietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months

DRUG

N-acetylcysteine active and silibin active

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months

DRUG

N-acetylcysteine active + high-dose silibin active

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Paolo Fanti, MD · South Texas Health Care System, San Antonio, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-02-28
Completion
2016-12-31

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 NCT01265563 on ClinicalTrials.gov