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El ensayo clínico NCT06989320 para Piedras en los riñones, Cálculos renales, Urolitiasis, Urolitiasis, oxalato de calcio, Nefrolitiasis, Nefrolitiasis de oxalato de calcio, Urolitiasis por oxalato, Saludable, Voluntario saludable está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease 80 Dietético

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06989320 es un estudio intervencionista para Piedras en los riñones, Cálculos renales, Urolitiasis, Urolitiasis, oxalato de calcio, Nefrolitiasis, Nefrolitiasis de oxalato de calcio, Urolitiasis por oxalato, Saludable, Voluntario saludable. Su estado actual es: reclutando. El estudio se inició el 27 de mayo de 2025, con el objetivo de reclutar a 80 participantes. Dirigido por la Universidad de Alabama en Birmingham, se espera que finalice el 31 de diciembre de 2031. Los datos se actualizaron por última vez en ClinicalTrials.gov el 31 de mayo de 2025.
Resumen
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, 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 amounts of ox...

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Descripción detallada
In this study the investigators propose to measure the production of oxalate by the body (endogenous oxalate synthesis), after equilibration on a low oxalate diet (<60 mg oxalate/day, 600-800 mg calcium/day) and estimate the importance of vitamin C and glycolate metabolism to oxalate production in both Calcium Oxalate Kidney Stone patients and matched controls by oral dosings of those two substances.

Phase 1. Scree...

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Título oficial

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Formers

Condiciones médicas
Piedras en los riñonesCálculos renalesUrolitiasisUrolitiasis, oxalato de calcioNefrolitiasisNefrolitiasis de oxalato de calcioUrolitiasis por oxalatoSaludableVoluntario saludable
Otros ID del estudio
Número del NCT
NCT06989320
Inicio del estudio (real)
2025-05-27
Última actualización
2025-05-31
Fecha de finalización (estimada)
2031-12-31
Inscripción (prevista)
80
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
oxalate synthesis
Objetivo principal
Ciencia básica
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalIdiopathic Calcium Oxalate Kidney Stone Patients
Low oxalate fixed diets. oral glycolate and ascorbic acid administration
Low-oxalate diet and glycolate dosing
Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
Oral glycolate dosing
Oral 13C-glycolate dosing (0.5 mg/kg)
Oral 13C- ascorbic acid dosing
Oral 13C- ascorbic acid dosing (0.75 mg/kg)
Comparador activoHealthy non-kidney stone forming individuals
Low oxalate fixed diets. oral glycolate and ascorbic acid administration
Low-oxalate diet and glycolate dosing
Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
Oral glycolate dosing
Oral 13C-glycolate dosing (0.5 mg/kg)
Oral 13C- ascorbic acid dosing
Oral 13C- ascorbic acid dosing (0.75 mg/kg)
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Estimated endogenous oxalate synthesis (oxalate mg/day)
Basal rate of endogenous oxalate synthesis estimated by repeat fasted hourly urine collections (mg/day)
1 day
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
24-hour urinary oxalate excretion on low oxalate diet
mean 24-hour urinary oxalate excretion on the low oxalate diet (mg/day)
2 days
contribution of ascorbic acid breakdown to urinary oxalate excretion
contribution of ascorbic acid breakdown to oxalate synthesis (%)
2 days
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
  • age 18-80 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%

  • 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
University of Alabama at Birmingham logoUniversidad de Alabama en Birmingham478 estudios activos para explorar
Parte responsable del estudio
Sonia Fargue, Investigador principal, Associate professor, University of Alabama at Birmingham
Contactos centrales del estudio
Contacto: Sonia Fargue, PhD, 205-975-6932, [email protected]
2 Centros del estudio en 1 países

Alabama

United States, Alabama University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Sonia Fargue, PhD, Contacto, 205-975-6932, [email protected]
Research Coordinator, Contacto, 205-934-5712, [email protected]
Sonia Fargue, PhD, Investigador principal
Reclutando

Texas

University of Texas South Western Medical Center, Dallas, Texas, 75390, United States
Naim Maalouf, MD, Contacto, [email protected]
Research Coordinator, Contacto, [email protected]
Naim Maalouf, MD, Investigador principal
Aún no recluta