Oxalate-Driven Host Responses in Kidney Stone Disease

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• Men and women between the ages of 18 and 60 years old.

• Able to provide informed consent.

• BMI between 20-30 kg/m2.

• Non-tobacco users or not pregnant/breastfeeding/nursing.

• Normal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Must accurately collect two 24-hour urine collections within 20% of the appropriate ratio of creatinine (mg)/body weight (kg) for respective gender.

• Healthy subjects: No history of CaOx KS or other medical conditions.

• Patients with CaOx KS: Recent stone composition \> 50% CaOx; no uric acid, struvite, or carbonate apatite stone content. Must be first-time or recurrent CaOx stone former (last stone event ≤ 3 years).

• Willing to not consume supplements (i.e. vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, and probiotics) for 2 weeks before the study and during the study.

• Willing to abstain from vigorous exercise during the study as this may compromise immune function.

• Willing to consume diets provided only by the UAB CCTS Bionutrition Core. No food allergies or intolerance to any of the foods on the study menus.

• Willing to accurately collect 24-hour urine samples, and to have blood drawn throughout the study.

• If on medications for KS prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), patients must be on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during the study. Patients should not take allopurinol for 2 weeks prior to screening since allopurinol has antioxidant properties.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Tanecia Mitchell, PhD
taneciamitchell@uabmc.edu
(205) 996-2292
Time Frame
Start Date: 2023-05-19
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 88
Treatments
Experimental: Healthy Participants
Healthy participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day washout period on a self-selected diet, and finally the opposite diet from the first for the last four days.
Experimental: Calcium Oxalate Kidney Stone
Calcium oxalate kidney stone participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day washout period on a self-selected diet, and finally the opposite diet from the first for the last four days.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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