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De klinische studie NCT06989320 voor Nierstenen, Nierstenen, Urolithiasis, Calciumoxalaat-urolithiasis, Nefrolithiase, Nefrolithiasis, calciumoxalaat, Oxalaat urolithiasis, Gezond, Gezonde vrijwilliger is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Universiteit van Alabama in BirminghamEndogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease 80 Dieet
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De klinische studie NCT06989320 is een interventioneel studie bij Nierstenen, Nierstenen, Urolithiasis, Calciumoxalaat-urolithiasis, Nefrolithiase, Nefrolithiasis, calciumoxalaat, Oxalaat urolithiasis, Gezond, Gezonde vrijwilliger met de status rekruterend. Het doel is om 80 deelnemers te includeren vanaf 27 mei 2025. De studie wordt geleid door de Universiteit van Alabama in Birmingham en de voltooiing is gepland op 31 december 2031. Laatste update op ClinicalTrials.gov: 31 mei 2025.
Beknopte samenvatting
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...
Toon meerUitgebreide beschrijving
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...
Toon meerOfficiële titel
Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Formers
Aandoeningen
NierstenenNierstenenUrolithiasisCalciumoxalaat-urolithiasisNefrolithiaseNefrolithiasis, calciumoxalaatOxalaat urolithiasisGezondGezonde vrijwilligerAndere studie-ID's
- IRB300014279-OSS
- R01DK137784 (Subsidie/contract van NIH (VS))
NCT-ID
Startdatum (Werkelijk)
2025-05-27
Laatste update geplaatst
2025-05-31
Verwachte einddatum
2031-12-31
Inschrijving (Geschat)
80
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
oxalate synthesis
Primaire doel
Basiswetenschap
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelIdiopathic 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) |
Actieve comparatorHealthy 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) |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Estimated endogenous oxalate synthesis (oxalate mg/day) | Basal rate of endogenous oxalate synthesis estimated by repeat fasted hourly urine collections (mg/day) | 1 day |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
- 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
Universiteit van Alabama in Birmingham478 actieve klinische studies om te verkennen- Universiteit van Texas Southwestern Medisch Centrum284 actieve klinische studies om te verkennen
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verantwoordelijke instantie
Sonia Fargue, Hoofdonderzoeker, Associate professor, University of Alabama at Birmingham
Centraal Contactpersoon
Contact: Sonia Fargue, PhD, 205-975-6932, [email protected]
2 Studielocaties in 1 landen
Alabama
United States, Alabama University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Sonia Fargue, PhD, Contact, 205-975-6932, [email protected]
Research Coordinator, Contact, 205-934-5712, [email protected]
Sonia Fargue, PhD, Hoofdonderzoeker
Rekruterend
Texas
University of Texas South Western Medical Center, Dallas, Texas, 75390, United States
Naim Maalouf, MD, Contact, [email protected]
Research Coordinator, Contact, [email protected]
Naim Maalouf, MD, Hoofdonderzoeker
Nog niet rekruterend