NCT05417568

Oxalate-Driven Host Responses in Kidney Stone Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens.

Detailed description

The purpose of this longitudinal study is to examine the effects of dietary oxalate on nanocrystalluria and the immune system. Oxalate is a small molecule found in plants and plant-derived food. It has been shown that meals containing high amounts of oxalate can increase urinary oxalate excretion, which is a risk factor for calcium oxalate kidney stones (CaOx KS). Small increases in oxalate can stimulate urinary crystals to form which can elicit an immune response. This study consists of having healthy subjects and patients with CaOx KS consume both low and oxalate enriched diets to evaluate the effect of oxalate on urinary crystals and immune responses. Participants will receive a low or high oxalate diet for 4 days prior to having a wash-out period for 6 days. Participants will then crossover to the opposite oxalate diet for four more days.

Conditions

• Kidney Stones

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low Oxalate Diet	Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.
DIETARY_SUPPLEMENT	High Oxalate Diet	Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

Timeline

• Start date: 2023-05-19
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2022-06-14
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States