Sulforaphane for Pediatric Kidney Disease

Overseen By Rebecca Levy, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Anticoagulants, Immunosuppression, Chemotherapeutics

Disqualifiers: Cancer, HIV, Transplant, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests sulforaphane, a natural compound in vegetables like broccoli, to determine its potential benefits for children with chronic kidney disease (CKD). The goal is to identify a safe and tolerable dose. Researchers will also examine whether this treatment can alter specific markers related to inflammation and oxidation, common in CKD. Children diagnosed with CKD who experience moderate to advanced symptoms might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anticoagulants, immunosuppression, or chemotherapeutic drugs.

Is there any evidence suggesting that sulforaphane is likely to be safe for children with chronic kidney disease?

Research has shown that sulforaphane is generally safe for use. Studies have found that products high in sulforaphane, such as broccoli extract, can be used safely for up to six months. Some individuals might experience minor stomach issues, but these are usually not serious. In studies involving children and young adults, the treatment proved safe and had positive effects.

This treatment remains in the early stages of testing, so more research is needed to confirm its safety for children with chronic kidney disease. However, these findings suggest that sulforaphane could be a safe option to explore further. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney disease?

Researchers are excited about sulforaphane for pediatric kidney disease because it offers a unique approach compared to current treatments. Unlike traditional medications that often focus on managing symptoms or slowing disease progression, sulforaphane, a compound found in cruciferous vegetables like broccoli, may have the potential to reduce inflammation and oxidative stress directly. This novel mechanism of action could lead to improved kidney function and overall health outcomes. Additionally, sulforaphane is a natural compound, which may present fewer side effects compared to synthetic drugs. This could be especially beneficial for children, who are more sensitive to medication side effects.

What evidence suggests that sulforaphane might be an effective treatment for pediatric kidney disease?

Research has shown that sulforaphane might slow kidney disease and reduce cell damage from harmful molecules. Some studies found that people taking sulforaphane experienced slower disease progression and improved urine test results related to kidney health. Early findings also suggest it can aid in detoxification and reduce inflammation, benefiting the kidneys. In this trial, participants will receive different dosages of sulforaphane based on their weight to evaluate its effectiveness. Although more research is needed, these early results are promising for sulforaphane's potential in managing chronic kidney disease. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children with moderate to advanced chronic kidney disease (CKD), specifically those with an eGFR of 20-59 mL/min/1.73m2. Parents must consent for participation. It's not suitable for kids under 30 kg, or those with cancer, HIV, organ transplants, heart issues, pregnancy plans, short life expectancy or on certain medications like anticoagulants.

Inclusion Criteria

Parents must be able to provide consent

I have been diagnosed with chronic kidney disease.

My kidney function is moderately to severely reduced.

Exclusion Criteria

Currently pregnant or plan to become pregnant

I am currently on blood thinners, immune system suppressors, or chemotherapy.

I have a heart condition affecting its structure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sulforaphane (SFN) supplementation to assess safe dosing and tolerability

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sulforaphane

Trial Overview The study tests the safety and tolerability of a supplement called Sulforaphane in children with CKD. The goal is to find out the right dose and see how it affects oxidative stress and inflammation markers in these patients.

How Is the Trial Designed?

Group I: Group 3 Active Control 1 Intervention

30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 1 tablet (30mg/d) \>90 lbs; 1 tablet (30 mg/d)

Group II: Group 1 Active Control 1 Intervention

30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 2 tablets (60mg/d) 70-90 lbs; 3 tablets (90mg/d) \>90 lbs; 4 tablets (120 mg/d)

Group III: Group 2 Active Control 1 Intervention

30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 2 tablets (60mg/d) \>90 lbs; 2 tablets (60 mg/d)

Sulforaphane is already approved in United States for the following indications:

Approved in United States as Avmacol ES for:

• None approved; used in clinical trials for various conditions including chronic kidney disease and prevention of age-associated cardiac and vascular dysfunction

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Renal Research Institute

Collaborator

Trials

35

Recruited

79,400+

Published Research Related to This Trial

A new ultra-fast and accurate method was developed to measure sulforaphane (SFN) and its precursor glucoraphanin (GR) in human urine, demonstrating over 87% recovery and low variability, which is crucial for studying their effects in humans.

After consuming broccoli sprouts, participants showed up to 40% bioavailability of SFN, indicating that dietary intake of broccoli can effectively deliver this beneficial compound to the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new ultra-rapid UHPLC/MS/MS method for assessing glucoraphanin and sulforaphane bioavailability in human urine. Dominguez-Perles, R., Medina, S., Moreno, DÁ., et al.[2021]

In a clinical trial with 50 healthy participants, sulforaphane was found to be significantly more bioavailable from a sulforaphane-rich beverage (SFR) compared to a glucoraphanin-rich beverage (GRR), with urinary excretion rates of 70% for SFR versus only 5% for GRR.

The study suggests that combining both SFR and GRR in future formulations could optimize dosing, allowing for both immediate and prolonged effects of sulforaphane, which may enhance its protective actions against cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Egner, PA., Chen, JG., Wang, JB., et al.[2022]

A phase I clinical study involving healthy volunteers showed that broccoli sprout extracts containing glucoraphanin and sulforaphane were safe and well-tolerated, with no significant adverse effects reported during the treatment period.

The study demonstrated that the isothiocyanate sulforaphane was excreted at a much higher rate (70.6% of the dose) compared to glucosinolates, indicating effective absorption and potential for protective health benefits against diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. Shapiro, TA., Fahey, JW., Dinkova-Kostova, AT., et al.[2022]

Sulforaphane (SF), a beneficial compound from broccoli, is absorbed more effectively from myrosinase-rich broccoli sprouts compared to glucoraphanin-rich broccoli powder, with a 74% recovery in urine from sprouts versus only 19% from the powder.

Combining broccoli sprouts with the powder improved SF absorption, suggesting that this combination could enhance the health benefits of broccoli products without causing any toxicity, as indicated by liver function tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulforaphane absorption and excretion following ingestion of a semi-purified broccoli powder rich in glucoraphanin and broccoli sprouts in healthy men. Cramer, JM., Jeffery, EH.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05797506

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol ... The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/74/NCT05153174/Prot_SAP_000.pdf

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol ... We hypothesize that daily intake of sulforaphane (Avmacol Extra Strength (ES)) can decrease kidney disease progression rate and decrease markers of oxidative ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8146218/

Randomized controlled trial of sulforaphane and metabolite ... Positive clinical effects as well as findings in urinary metabolites were also reported in an open-label trial in children and young adults ...

4. trialx.com trialx.com/clinical-trials/listings/220841/safety-feasibility-and-efficacy-of-sulforaphane-avmacol-extra-strength-in-chronic-kidney-disease/

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol ... The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12451241/

Sulforaphane as a potential therapeutic agent For healthy subjects, SFN enhanced detoxification and reduced inflammation. In cancer patients, SFN showed promise in early-stage prostate and breast cancer, ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1070/sulforaphane

Sulforaphane - Uses, Side Effects, and More Sulforaphane and sulforaphane-rich broccoli extract products have been used safely for up to 6 months. It's usually well-tolerated. Side effects might include ...