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Active, Not Recruiting

NCT Number: NCT04608903

Effects of Sulforaphane for Patients With Chronic Kidney Disease

Patients with Chronic Kidney Disease (CKD) have many complications associated with inflammation, oxidative stress and intestinal dysbiosis, which are closely related to the progression of kidney failure and cardiovascular disease. Sulforaphane, an isothiocyanate found in cruciferous vegetables (Family: Brassicaceae) is recognized as one of the most important activators of erythroid nuclear factor 2 related to factor 2 (Nrf2). However, clinical evidence to assess the effects of sulforaphane in patients with CKD is scarce, and there are no studies that have investigated its effects on the expression of genes and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of sulforaphane on transcription factors and inflammatory markers in patients with CKD.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denise Mafra

Rio de Janeiro, 22260050, Brazil

About this study

This is a longitudinal, randomized, crossover study with patients with CKD on hemodialysis and in non-dialysis patients.

Both groups will receive 4g of sulforaphane per day for 2 months and the placebo group will receive 4g of corn starch colored with chlorophyll for 2 months. Peripheral blood mononuclear cells (PBMC) are being isolated for expression of Nrf2, NF-kB, and NADPH quinone oxidoreductase 1 (NQO1), HO-1, VCAM-1, E-selectin, NLRP3, IL-1B, IL 18, PGC1-α, sentrins, NRF2, NRF-1 e TFAM mRNA expression by a quantitative real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) will be assessed using an enzyme-linked immunosorbent assay (ELISA).The serum concentration of other cytokines and growth factors will be detected by means of a multiparametric immunoassay based on magnetic microspheres marked with XMap (Luminex Corp, USA) before and after supplementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Criteria

Inclusion criteria

  • Aged 18 to 75 years
  • Clinical diagnosis of Chronic Kidney Disease
  • Conservative treatment group: CKD stages 3 and 5 receiving nutritional treatment for at least 6 months
  • Hemodialysis group: Hemodialysis patients for more than 6 months

Exclusion criteria

  • Patients pregnant
  • Smokers
  • Using antibiotics in the last 3 months
  • Autoimmune diseases
  • Clinical diagnosis of infectious diseases
  • Clinical diagnosis of Cancer
  • Clinical diagnosis of AIDS

Treatment and study plan

L-sulforaphane 1%

Dietary Supplement

Administration of 4g L-sulforaphane per day, for 2 months

Placebo Group

Dietary Supplement

Administration of 4g corn starch colored with chlorophyll, per day, for 2 months

Primary outcomes

  1. Antioxidant and anti-inflammatory biomarker

    Time frame: 6 months

    Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)

  2. Inflammatory biomarker

    Time frame: 6 months

    Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)

Secondary outcomes

  1. Uremic toxins

    Time frame: 6 months

    Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Oct 29, 2020
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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