Влияние пищевого фосфора на баланс и кинетику фосфора и кальция в организме при умеренной ХБП
The aim of the study is to look at the effects of dietary phosphorus on phosphorous and calcium whole-body balance and kinetics in moderate chronic kidney disease (CKD). N = 14 enrolled subjects will be randomly assigned to a cross-over order of (A) Low P Diet, High P Diet. Each cross-over phase will be 19 days and consist of a 7-day outpatient, controlled diet period, followed by a 5- day inpatient, controlled diet, balance, and kinetic study period, followed by a second 7-day outpatient, controlled diet period.
Обзор исследования
Подробное описание
Chronic kidney disease (CKD) affects approximately 37 million (1 in 7) U.S. adults, most of whom experience mineral and bone disorders (CKD-MBD) that increase risk for cardiovascular events, bone fractures, and death. Dietary and pharmaceutical treatments for CKD-MBD have diverse effects on serum calcium and phosphorus levels, but their effects on the underlying physiological processes of calcium and phosphorus balance are largely unknown. This study aims to determine the effects of a low versus high phosphorus bioaccessibility diet on whole-body calcium and phosphorus balance and kinetics, including measures such as estimated intestinal absorption. This study will be a randomized two-phase cross-over design trial that will include a controlled study diet, a phosphorus isotope as a tracer for kinetic modeling, stool and urine collections, and blood draws. After screening, eligible participants who choose to enroll in the study will be asked to participate in two cross-over sessions, each of approximately 3 weeks (19 days) duration during which time all food will be provided according to the randomized diet intervention assignment. After the first week on the study diet, participants will be asked to stay at the clinical research center when they will be given oral and intravenous doses of phosphorus isotope. Serial blood draws and complete urine and fecal collections will be made for 5 days, then the final week will only include blood draws. Between cross-over sessions, there will be a washout period of 1-3 weeks. Participants will then switch diets and repeat the same study process as the first session. Calcium and phosphorus whole-body balance, intestinal absorption, renal excretion, and movement to and from bone will be determined for both minerals. This project will provide foundational knowledge of calcium and phosphorus physiology in CKD that will support progress towards preventing morbidity and mortality associated with CKD-MBD.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Kathleen Hill Gallant, PhD
- Номер телефона: 612-625-5285
- Электронная почта: hillkm@umn.edu
Учебное резервное копирование контактов
- Имя: Study Coordinator
- Электронная почта: KidneyNutrition@umn.edu
Места учебы
-
-
Indiana
-
Indianapolis, Indiana, Соединенные Штаты, 46202
- Indiana University School of Medicine
-
Контакт:
- Mary Balmes-Fenwick
- Номер телефона: 317-948-7772
- Электронная почта: mbalmes@iu.edu
-
Главный следователь:
- Sharon M Moe, MD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Men or women, ages 30-75 years old, any race or ethnicity
- Moderate CKD, defined by KDIGO as eGFR category 3b (30-44 mL/min) or 4 (16-29 mL/min) with albuminuria categories A1-A3
- Serum intact parathyroid hormone above assay normal limit
- 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 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 based on National Academy of Medicine (then Institute of Medicine) criteria.
Exclusion Criteria:
- Plans to initiate dialysis within 6 months
- Hypercalcemia defined as corrected serum calcium >9.8 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, bariatric surgery, or chronic diarrhea/malabsorption
- Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension in the opinion of their physician
- Pregnant or breastfeeding
- Prescribed and taken a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, PTH analogues, and other medications that may alter Ca and P metabolism within past 4 weeks
- Non-English speaking
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: CKD patients group 1
assigned to Low P Diet (LP) then High P Diet (HP), |
Cross-over order of LP then HP diet. Each cross-over phase will be 19 days and consist of a 7-day outpatient, controlled diet period, followed by a 5-day inpatient, controlled diet, balance, and kinetic study period, followed by a second 7-day outpatient, controlled diet period. |
|
Экспериментальный: CKD patients group 2
assigned to HP, then LP. |
Cross-over order of HP then LP diet. Each cross-over phase will be 19 days and consist of a 7-day outpatient, controlled diet period, followed by a 5-day inpatient, controlled diet, balance, and kinetic study period, followed by a second 7-day outpatient, controlled diet period. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Phosphorus Balance
Временное ограничение: 5 days
|
Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed |
5 days
|
|
Calcium Balance
Временное ограничение: 5 days
|
Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed |
5 days
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Fractional phosphorus absorption
Временное ограничение: 12 days
|
Determined by kinetic modeling of serum, urine, and stool P-33 isotope after oral and IV isotope administrations |
12 days
|
|
Bone phosphorus balance
Временное ограничение: 12 days
|
Determined by kinetic modeling of serum, urine, and stool P-33 isotope after oral and IV isotope administrations |
12 days
|
|
Bone calcium balance
Временное ограничение: 5 days and 12 days
|
Determined from the natural stable isotope ratio of 44-Ca to 42-Ca in serum and urine |
5 days and 12 days
|
|
Urine phosphorus
Временное ограничение: 1 week
|
Determined from the 24-hour urine collections over 1 week (daily average) |
1 week
|
|
Urine calcium
Временное ограничение: 1 week
|
Determined from the 24-hour urine collections over 1 week (daily average) |
1 week
|
|
Net phosphorus absorption
Временное ограничение: 1 week
|
Determined by analysis of phosphorus content in complete stool collections, subtracted from the diet phosphorus content consumed, divided by the diet phosphorus consumed. |
1 week
|
|
Net calcium absorption
Временное ограничение: 1 week
|
Determined by analysis of calcium content in complete stool collections, subtracted from the diet calcium content consumed, divided by the diet phosphorus consumed |
1 week
|
|
Creatinine clearance
Временное ограничение: 2hours, day 8
|
Creatinine clearance will be determined from the 2-hour fasting urine and a mid-point blood sample collected on Day 8. |
2hours, day 8
|
|
Serum Fibroblast growth factor-23
Временное ограничение: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum Parathyroid hormone
Временное ограничение: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum 1,25-dihydroxyvitamin D
Временное ограничение: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum phosphate
Временное ограничение: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum calcium
Временное ограничение: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Kathleen Hill Gallant, PhD, University of Minnesota
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- TBD2
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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