Controlled Diet for Kidney Stones

DW
Overseen ByDemond Wiley
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific gene mutation affects oxalate production, a compound linked to kidney stones. Participants will follow a special low-oxalate diet and undergo blood and urine tests to measure oxalate levels. The study targets individuals who have had calcium oxalate kidney stones, carry a specific gene mutation, and are willing to adhere to a controlled diet for five days.

As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new insights and treatments for kidney stones.

What prior data suggests that this dietary intervention is safe?

Previous studies have shown that dietary changes can safely help manage kidney stones. Research indicates that diet can lower the risk of developing stones, with a low-oxalate diet, like the one in this study, proving especially effective.

Regarding glycolate, specific safety data from direct sources is not available. As this is an early-phase study, the safety information may not be as clear as in later-phase studies. However, past research has not associated glycolate with major safety concerns.

Overall, the controlled diet and glycolate appear well-tolerated based on available data. Participants can feel reassured about the safety of these methods.12345

Why are researchers excited about this trial?

Researchers are excited about the controlled diet for kidney stones because it offers a non-invasive, dietary approach to managing oxalate levels, which are a key factor in stone formation. Unlike current treatments that often involve medication or surgery, this method focuses on altering diet to naturally reduce oxalate levels. This could potentially minimize side effects and provide a more sustainable, long-term solution for patients. Additionally, the integration of glycolate administration might enhance the effectiveness of the diet, offering a novel combination therapy that has not been extensively explored before.

What evidence suggests that this controlled diet is effective for reducing oxalate levels in kidney stone patients?

Studies have shown that dietary changes can reduce the risk of kidney stones, particularly calcium oxalate stones. Eating the right foods effectively prevents the recurrence of kidney stones. Research indicates that a diet with normal calcium levels and reduced animal protein can lower the chance of stones returning by 51%. Monitoring mineral salt intake also benefits those with kidney stones. Drinking plenty of fluids is known to lower the risk of stones forming again. These findings support the idea that a controlled diet, which participants in this trial will follow, can effectively manage kidney stones.12367

Who Is on the Research Team?

KW

Kyle Wood, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for people who have had calcium oxalate kidney stones and carry a single (heterozygous) mutation in the AGXT gene, confirmed by genetic testing. Participants must be willing to follow a special low-oxalate diet for five days.

Inclusion Criteria

I have had calcium oxalate kidney stones in the past.
I have one mutated copy of the AGXT gene confirmed by genetic testing.
willingness to comply with a controlled diet for five days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Controlled Dietary Study

Participants consume a controlled low-oxalate diet and provide urine and blood samples to measure oxalate levels

5 days
Daily visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Controlled Diet
  • Glycolate Administration

Trial Overview

The study tests how a controlled low-oxalate diet affects oxalate levels in people with an AGXT gene mutation and kidney stone history. Blood and urine samples will be collected to measure changes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Controlled Dietary StudyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Nutrition and Kidney Stone Disease - PMC

Diet modification is an effective method to correct urinary risk factors for kidney stone formation, particularly of the most common stone type calcium oxalate.

Nutrition therapy for the prevention of kidney stones

Nutrition therapy is well established in clinical practice as a central strategy for reduction of kidney stone recurrence. High quality evidence ...

Targeted versus empiric approach for prevention of ...

The Emp group had a 33% reduction in dietary oxalic acid intake (p = 0.02), but no significant changes in intakes of water, sodium, animal-based protein, or ...

Kidney Stone Diet Plan and Prevention

A diet low in calcium actually increases your chances of developing kidney stones. Don't reduce the calcium in your diet. Work to cut back on the sodium in ...

Dietary changes and pharmacologic interventions may ...

Pharmacologic interventions were assessed in 23 studies. In adults, thiazide diuretics demonstrated a small reduction in recurrence at 3 years ( ...

Diet, Fluid, or Supplements for Secondary Prevention of ...

High fluid intake decreased risk of recurrent nephrolithiasis. Reduced soft drink intake lowered risk in patients with high baseline soft drink consumption.

Nutritional Management of Kidney Stones (Nephrolithiasis)

Prospective study investigating the influence of nutritional intervention on biochemical profiles in patients with recurrent urolithiasis.