Effetti del fosforo alimentare sull'equilibrio e sulla cinetica dell'intero corpo di fosforo e calcio nella malattia renale cronica moderata
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kathleen Hill Gallant, PhD
- Numero di telefono: 612-625-5285
- Email: hillkm@umn.edu
Backup dei contatti dello studio
- Nome: Study Coordinator
- Email: KidneyNutrition@umn.edu
Luoghi di studio
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University School of Medicine
-
Contatto:
- Mary Balmes-Fenwick
- Numero di telefono: 317-948-7772
- Email: mbalmes@iu.edu
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Investigatore principale:
- Sharon M Moe, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Phosphorus Balance
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fractional phosphorus absorption
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 week
|
Determined from the 24-hour urine collections over 1 week (daily average) |
1 week
|
|
Urine calcium
Lasso di tempo: 1 week
|
Determined from the 24-hour urine collections over 1 week (daily average) |
1 week
|
|
Net phosphorus absorption
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum Parathyroid hormone
Lasso di tempo: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum 1,25-dihydroxyvitamin D
Lasso di tempo: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum phosphate
Lasso di tempo: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum calcium
Lasso di tempo: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kathleen Hill Gallant, PhD, University of Minnesota
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Altri numeri di identificazione dello studio
- TBD2
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