Phosphate Assessment in Chronic Kidney Disease Patients Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability.
Investigators will address the following specific aims: 1). To explore novel pathways of phosphate metabolism and assess the influence of CKD status on these metabolic pathways. 2). To identify novel biomarkers for phosphate overload that reflect changes in dietary phosphorus intake. 3). To develop a compound phosphate overload index that measures dietary phosphorus intake with high validity and reliability.
This study will provide novel insights into phosphate metabolism and the assessment of phosphate overload in CKD patients. This investigation aims to provide preliminary data to further studies for the development of reliable biomarkers in CKD patients, which could contribute significantly to early interventions and improve health outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men or women aged 18 years or older, of any race/ethnicity
Women must either be post-menopausal or have no monthly menstrual cycle
Estimated total daily energy expenditure (TDEE) of 1700 - 2700 calories
eGFR >15 ml/min/1.73m2 - < 60 ml/min/1.73m2 for the CKD group (CKD Stage 3 or Stage 4)
Disqualifiers
Pregnant, currently breastfeeding, or <3 months postpartum
Current dialysis or kidney transplant patient
Current use of insulin or chemotherapy drugs
Smokes cigarettes or uses e-cigarettes (vapes)
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary Phosphorus Intake
Dietary supplementDietary phosphorus intake of about 777 mg/day for 7 days, followed by an increase to about 1,277mg/day for another 7 days, and a further increase to about 1,777 mg/day for the subsequent 7 days. The meal plan will maintain consistent intake of calories, sodium, potassium, and calcium throughout the 21-day intervention. 1200 mg/day and 1700 mg/day phosphorus diets will be achieved by providing participants with sodium phosphate capsules and 777 mg/day meals.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Chronic Kidney Disease PatientsActive comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in serum phosphate levels
Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 32
Change in parathyroid hormone (PTH) levels
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 33
Change in C-terminal Fibroblast Growth Factor 23 (FGF23) levels
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 34
Change in Fibroblast Growth Factor 23 (FGF23) levels
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 3Secondary outcomes
1
Change in serum calcium levels
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 32
Change in Alkaline Phosphatase (ALP) levels
Circulating serum ALP levels (U/L) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 33
Change in 1,25-dihydroxyvitamin D levels
Circulating serum 1,25-dihydroxyvitamin D levels (pg/mL) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 34
Change in Bone-Specific Alkaline Phosphatase (BALP) levels
Circulating serum BALP levels (U/L) will be measured using standard clinical laboratory assays
Time frame
Baseline, week 1, week 2, and week 3Other outcomes
1
Exploratory: Phosphate-related biomarkers identified using proteomics platforms
For the proteomics analysis, only novel biomarkers associated with the phosphate diet will be reported, and their quantitative values are expressed as relative fluorescence units (RFU).
Time frame
Baseline, week 1, week 2, week 32
Exploratory: Phosphate-related biomarkers identified using metabolomics platforms
For the metabolomic analysis, only novel biomarkers associated with the phosphate diet will be reported. These features are not yet chemically identified, quantitative results are expressed as relative abundances.
Time frame
Baseline, week 1, week 2, week 3Sponsors and contacts
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Source ClinicalTrials.gov