Virkninger af diætfosfor på fosfor og calcium i hele kroppens balance og kinetik ved moderat CKD
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Kathleen Hill Gallant, PhD
- Telefonnummer: 612-625-5285
- E-mail: hillkm@umn.edu
Undersøgelse Kontakt Backup
- Navn: Study Coordinator
- E-mail: KidneyNutrition@umn.edu
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University School of Medicine
-
Kontakt:
- Mary Balmes-Fenwick
- Telefonnummer: 317-948-7772
- E-mail: mbalmes@iu.edu
-
Ledende efterforsker:
- Sharon M Moe, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Phosphorus Balance
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fractional phosphorus absorption
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 week
|
Determined from the 24-hour urine collections over 1 week (daily average) |
1 week
|
|
Urine calcium
Tidsramme: 1 week
|
Determined from the 24-hour urine collections over 1 week (daily average) |
1 week
|
|
Net phosphorus absorption
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum Parathyroid hormone
Tidsramme: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum 1,25-dihydroxyvitamin D
Tidsramme: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum phosphate
Tidsramme: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
|
Serum calcium
Tidsramme: Day1, Day8
|
Measured in a fasting blood collection on Day 1 and Day 8. |
Day1, Day8
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kathleen Hill Gallant, PhD, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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