Efectos de la Restricción Dietética de Fósforo en el Balance de Calcio y Fósforo en Pacientes con Enfermedad Renal Crónica
This study aims to investigate how restricting dietary phosphorus intake affects calcium and phosphorus balance in patients with chronic kidney disease, through analyzing calcium and phosphorus content in urine and stool collections and modeling isotope kinetics in serum and urine.
High Phosphorus Diet
+ Low Phosphorus Diet
Trastornos del metabolismo del calcio+20
+ Enfermedades Óseas Metabólicas
+ Enfermedades Urogenitales
Estudio de Ciencia Básica
Resumen
Fecha de inicio: 31 de agosto de 2020
Fecha en la que se inscribió al primer participante.This study focuses on understanding how calcium and phosphorus are processed in the bodies of individuals with moderate Chronic Kidney Disease (CKD). The main aim is to gather preliminary data on how a common dietary restriction of phosphorus impacts calcium and phosphorus balance and movement in these patients. This research is important as it could support a larger future clinical study, potentially improving care for those with CKD. Participants in this study will be assigned to one of two controlled diets: either a low calcium/high phosphorus diet or a low calcium/low phosphorus diet. After a week of following the diet at home, participants will spend a week in the hospital for full balance testing, including a 48-hour calcium and phosphorus absorption test. Following a break, participants will then switch to the other diet. The study measures the balance and absorption of calcium and phosphorus by analyzing their content in complete 24-hour urine and stool collections, and by using kinetic modeling of isotopes after oral and IV administrations. The results could provide valuable insights into dietary management for individuals with CKD.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 3 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Ciencia Básica
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 30 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Men or women, ages 30-75 years old, any race or ethnicity * Moderate chronic kidney disease * Female subjects must be postmenopausal (\>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test * Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study * Willing to discontinue nutritional supplements (e.g. vitamin D, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study * Adequate vitamin D status defined as serum 25D \> 20 ng/mL Exclusion Criteria: * Plans to initiate dialysis within 6 months * Hypercalcemia defined as serum calcium \>10.5 mg/dL within past 3 months * Hyperkalemia defined as serum potassium \>5.5 mg/dL within past 3 months * Hyperphosphatemia defined as serum phosphate \>5.5 mg/dL within past 3 months * Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery * Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension * Pregnant or breastfeeding * Prescribed a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter Ca and P metabolism within past 30 days
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación