Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06331546
Other study ID # IRB300004693
Secondary ID R01DK137784
Status Recruiting
Phase N/A
First received
Last updated
Start date April 17, 2024
Est. completion date December 31, 2031

Study information

Verified date May 2024
Source University of Alabama at Birmingham
Contact Sonia Fargue, PhD
Phone 2059756932
Email sfargue@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

In this study the investigators propose to measure the net gastrointestinal absorption of oxalate both by food-bound oxalate, using low- (<60 mg/day) and high- (250-300 mg/day) oxalate diets (600-800 mg daily calcium in both), and by the soluble 13C2-oxalate oral test in both Calcium Oxalate Kidney Stone patients and matched controls. Phase 1. Screening and low-oxalate diet 24-hr urinary excretions. Between the University of Alabama at Birmingham (UAB) and the University of Texas Southwestern Medical Center (UTSW), the study will enroll 40 subjects with idiopathic Calcium Oxalate Kidney Stone (20 Males/20 Females) and 40 non-kidney stone forming controls (20 Males/20 Females). Participants in the two groups will be matched for age (within 10 yrs) and gender. Screening will include blood complete metabolic profile and two 24-hr urine specimens collected at home on self-choice diets and anthropometric measurements. Participants will then ingest the controlled low-oxalate (<60 mg/d) diet for 5 consecutive days and collect two 24-hr urines after 2 days of dietary equilibration. Phase 2. 13C2-Oxalate gut absorption tests. On Day 5, participants will arrive after an overnight fast in the research unit to undergo the 13C2-oxalate absorption test. After a 1-hour baseline urine collection, they will ingest an oral load containing 100 mg 13C2-oxalate and 1 g sucralose, dissolved in bottled water. For the next 9 hrs, blood and urine will be collected hourly, and breath as more time points. They will remain on the fixed diet for 24 hrs with a breakfast 2 hours after the load, lunch 6 hrs post-load, and dinner at home 12 hrs post-load. They will collect the remainder of their 24-hr urine at home and the totality of the stool eliminated during the first 24 hrs after the load using kits provided. Phase 3. High-oxalate diet 24-hr urinary excretions. After a minimum of 1 week wash-out period, during which participants will eat freely, participants will consume the high oxalate (250-300 mg/day) diet for the next 4 days. Two 24-hr urine specimens will be collected after 2 days of equilibration and a fasting blood draw on the morning of Day 5. .


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2031
Est. primary completion date December 31, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - age 18-70 yrs - Body Mass Index > 18.5 kg/m2 - Normal fasting serum electrolytes on comprehensive metabolic profile - Willing to ingest fixed diets - Willing to stop supplements (vitamins including vitamin C, calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during study. - For stone formers: first time or recurrent Calcium Oxalate stone former. Composition of most recent stone = 50% calcium oxalate if available, uric acid component <20% Exclusion Criteria: - Chronic Kidney Disease stage 4-5 - Primary hyperoxaluria, Enteric (secondary) hyperoxaluria - Liver, bowel, endocrine or renal diseases (other than idiopathic Calcium Oxalate kidney stones) or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Celiac disease, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion, Chronic diarrhea, Bariatric surgery, Inflammatory bowel disease - Pregnancy or breast-feeding - Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus - Active malignancy or treatment for malignancy within 12 months prior to screening - Utilization of immunosuppressive medication - Uncontrolled hypertension or diabetes - Diabetes type 1 - Chronic NSAID use

Study Design


Intervention

Dietary Supplement:
Low-oxalate diet
4 days of fixed eucaloric diet with low oxalate (<60 mg/day), normal calcium content (600-1000 mg/day)
High-oxalate diet
4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium content (600-1000 mg/day)
Other:
soluble oxalate gut absorption test
Oral ingestion of 13C2-oxalate and sucralose.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States UTSW Dallas Texas

Sponsors (3)

Lead Sponsor Collaborator
University of Alabama at Birmingham National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Net Gastrointestinal absorption of food-bound oxalate difference between 24-hour urinary oxalate excretion on the high oxalate diet and the low oxalate diet, normalized to the difference in dietary oxalate composition of the two diets (%) 4 day
Secondary Absorption of soluble 13C2-oxalate Proportion of 13C2-oxalate recovered in urine to the amount orally ingested (%) 1 day
Secondary Estimated endogenous oxalate synthesis (oxalate mg/day) 24-hour urinary oxalate excretion on the low oxalate diet (mg/day) 2 days
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1