Diet and Oxalate Absorption for Kidney Stones
Trial Summary
Will I have to stop taking my current medications?
The trial requires participants to stop taking supplements like vitamins, calcium, and herbal supplements for 2 weeks before and during the study. The protocol does not specify if you need to stop other medications, so it's best to discuss with the study team.
What data supports the effectiveness of the treatment for kidney stones?
Research shows that a high calcium diet can help protect against the formation of calcium oxalate stones, which are a common type of kidney stone. Additionally, studies indicate that a high-oxalate diet increases oxalate absorption in the gut, which can contribute to stone formation, suggesting that managing dietary oxalate intake is important for reducing kidney stone risk.12345
Is a high-oxalate diet safe for humans?
Research shows that a high-oxalate diet can increase oxalate absorption in the body, but it does not mention any specific safety concerns for healthy individuals. However, people with a high rate of oxalate absorption or certain intestinal conditions might experience increased urinary oxalate, which could be a risk factor for kidney stones.12678
How does the dietary oxalate treatment for kidney stones differ from other treatments?
This treatment focuses on adjusting dietary oxalate intake to manage kidney stones, which is unique because it targets the absorption of oxalate in the intestines rather than just reducing oxalate excretion. Unlike other treatments, it involves a dietary approach that can either increase or decrease oxalate intake to study its effects on stone formation.128910
What is the purpose of this trial?
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate.The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones.Participants will* ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time* ingest a soluble form of oxalate and sugar preparations to test gut permeability* collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test
Research Team
Sonia Fargue, M.D., Ph.D.
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
This trial is for adults who've had calcium oxalate kidney stones and healthy volunteers without a history of these stones. Participants will follow specific diets and undergo tests to study how their bodies handle oxalate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Low-oxalate diet and initial tests
Participants ingest a controlled low-oxalate diet for 5 days and collect urine samples for analysis
13C2-Oxalate gut absorption test
Participants undergo the 13C2-oxalate absorption test with hourly blood and urine collections
Wash-out period
Participants have a wash-out period where they eat freely before the next phase
High-oxalate diet
Participants consume a high-oxalate diet for 4 days and collect urine samples for analysis
Follow-up
Participants are monitored for safety and effectiveness after the dietary interventions
Treatment Details
Interventions
- High-oxalate diet
- Low-oxalate diet
- soluble oxalate gut absorption test
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Texas Southwestern Medical Center
Collaborator