Effects of Sulforaphane for Patients With Chronic Kidney Disease

NCT04608903 | Active Not Recruiting DMC

• 1 other identifier: DeniseMafra11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Antioxidant and anti-inflammatory biomarker

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

  6 months

• Inflammatory biomarker

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

  6 months

Secondary Outcomes (1)

• Uremic toxins

  6 months

Study Arms (2)

Sulforaphane Group

EXPERIMENTAL

Administration of 4g L-sulforaphane per day, for 2 months and after the washout period (2 months) the groups will be crossed and will receive the same amount of placebo as the other group for 2 months.

Dietary Supplement: L-sulforaphane 1%

Placebo Group

PLACEBO COMPARATOR

Administration of 4g of corn starch colored with chlorophyll, per day, for 2 months and then after the washout period (2 months) the groups will be crossed and will receive the same amount of sulfarophane as the treatment group.

Dietary Supplement: Placebo Group

Interventions

L-sulforaphane 1% DIETARY_SUPPLEMENT

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

Sulforaphane Group

Placebo Group DIETARY_SUPPLEMENT

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, 22260050, Brazil

Location

Related Publications (1)

• Cardozo LFMF, Alvarenga LA, Ribeiro M, Dai L, Shiels PG, Stenvinkel P, Lindholm B, Mafra D. Cruciferous vegetables: rationale for exploring potential salutary effects of sulforaphane-rich foods in patients with chronic kidney disease. Nutr Rev. 2021 Oct 11;79(11):1204-1224. doi: 10.1093/nutrit/nuaa129.

  PMID: 33338213 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sulforaphane group or Placebo group. Thus, 52 participants with CKD under conservative treatment will be recruited at the Renal Nutrition Clinic of UFF and 70 patients under regular HD treatment

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: October 29, 2020
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)