[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07368946":3,"trial-entities:NCT07368946":157,"trial-summary:NCT07368946":162},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":42,"secondary_outcomes":60,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":123,"locations":126,"central_contacts":148,"overall_officials":152,"references":155,"see_also_links":156},"NCT07368946","STU-2024-1240","Phosphate Assessment in Chronic Kidney Disease Patients Study","A Pilot Feeding Study to Assess Phosphate Overload in Patients With Chronic Kidney Disease","RECRUITING","2026-12-31","2026-01","2026-01-28","2025-05-09","University of Texas Southwestern Medical Center","OTHER",false,"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.\n\nInvestigators 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.\n\nThis 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.","Specifically, study team propose recruiting 30 participants with CKD and 30 without CKD to investigate the responses of blood metabolites and known biomarkers to a 21-day diet intervention. The intervention will consist of a dietary phosphorus intake of about 777 mg\u002Fday for 7 days, followed by an increase to about 1,277mg\u002Fday for another 7 days, and a further increase to about 1,777 mg\u002Fday for the subsequent 7 days. 1200 mg\u002Fday and 1700 mg\u002Fday phosphorus diets will be achieved by providing participants with sodium phosphate capsules and 777 mg\u002Fday meals. The meal plan will maintain consistent intake of calories, sodium, potassium, and calcium throughout the 21-day intervention. Sodium, calcium, and potassium content will not change significantly throughout the intervention. The overnight fasting blood and 24-hour and random urine samples will be collected at the baseline and end of each phase.",[19,20],"Chronic Kidney Disease (Stage 3-4)","Chronic Kidney Disease Mineral and Bone Disorder",[22,23,24,25,26],"chronic kidney disease","study diet","feeding study","pilot","oral phosphate feeding","INTERVENTIONAL","DIAGNOSTIC",[30],"NA",{"count":32,"type":33},60,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DIETARY_SUPPLEMENT","Dietary Phosphorus Intake","Dietary phosphorus intake of about 777 mg\u002Fday for 7 days, followed by an increase to about 1,277mg\u002Fday for another 7 days, and a further increase to about 1,777 mg\u002Fday for the subsequent 7 days.\n\nThe meal plan will maintain consistent intake of calories, sodium, potassium, and calcium throughout the 21-day intervention.\n\n1200 mg\u002Fday and 1700 mg\u002Fday phosphorus diets will be achieved by providing participants with sodium phosphate capsules and 777 mg\u002Fday meals.",[40,41],"Chronic Kidney Disease Patients","Control Group",[43,47,50,53,56],{"measure":44,"description":45,"timeFrame":46},"Change in serum phosphate levels","Circulating serum phosphate levels (mg\u002FdL) will be measured using standard clinical laboratory assays","Baseline, week 1, week 2, and week 3",{"measure":48,"description":49,"timeFrame":46},"Change in parathyroid hormone (PTH) levels","Circulating PTH levels (pg\u002FmL) will be measured using standard clinical laboratory assays",{"measure":51,"description":52,"timeFrame":46},"Change in C-terminal Fibroblast Growth Factor 23 (FGF23) levels","Circulating C-terminal FGF23 levels (RU\u002FmL) will be measured using standard clinical laboratory assays",{"measure":54,"description":55,"timeFrame":46},"Change in Fibroblast Growth Factor 23 (FGF23) levels","Circulating FGF23 levels (pg\u002FmL) will be measured using standard clinical laboratory assays",{"measure":57,"description":58,"timeFrame":59},"Phosphate burden indices","Phosphate burden indices, developed using machine learning methods to systematically incorporate both known biomarkers and novel biomarkers. No units have been identified, we anticipate creating a score.","Baseline, week 1, week 2, week 3",[61,64,67,70,73,76],{"measure":62,"description":63,"timeFrame":46},"Change in serum calcium levels","Circulating serum calcium levels (mg\u002FdL) will be measured using standard clinical laboratory assays",{"measure":65,"description":66,"timeFrame":46},"Change in Alkaline Phosphatase (ALP) levels","Circulating serum ALP levels (U\u002FL) will be measured using standard clinical laboratory assays",{"measure":68,"description":69,"timeFrame":46},"Change in 1,25-dihydroxyvitamin D levels","Circulating serum 1,25-dihydroxyvitamin D levels (pg\u002FmL) will be measured using standard clinical laboratory assays",{"measure":71,"description":72,"timeFrame":46},"Change in Bone-Specific Alkaline Phosphatase (BALP) levels","Circulating serum BALP levels (U\u002FL) will be measured using standard clinical laboratory assays",{"measure":74,"description":75,"timeFrame":46},"Change in urinary calcium levels","Circulating urinary calcium excretion levels (mg\u002Fday) will be measured using standardized laboratory urine assays",{"measure":77,"description":78,"timeFrame":46},"Change in urinary phosphorus levels","Circulating urinary phosphorus excretion levels (mg\u002Fday) will be measured using standardized laboratory urine assays","ALL","18 Years",null,true,{"inclusion":84,"exclusion":91,"raw_text":122},[85,86,87,88,89,90],"Men or women aged 18 years or older, of any race\u002Fethnicity","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\u002Fmin\u002F1.73m2 - \\\u003C 60 ml\u002Fmin\u002F1.73m2 for the CKD group (CKD Stage 3 or Stage 4)","eGFR ≥ 60 ml\u002Fmin\u002F1.73m2 and negative urine protein on dipstick test for the non-CKD group","English speaking",[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121],"Pregnant, currently breastfeeding, or \\\u003C3 months postpartum","Current dialysis or kidney transplant patient","Current use of insulin or chemotherapy drugs","Smokes cigarettes or uses e-cigarettes (vapes)","Uses nicotine products or other recreational drugs","Medical history of stroke or myocardial infarction (MI)","Medical history of conditions that can affect phosphate metabolism (i.e., uncontrolled thyroid disorder, parathyroid disorder, or gastrointestinal malabsorption disorders \\[Crohn's, ulcerative colitis, and celiac disease\\], cirrhosis)","Current use of certain medications that directly alter phosphate levels (i.e., phosphate binders; phosphate supplements, irregular use of iron)","Regular use of laxatives","Hypo- or hyperphosphatemia (serum phosphate \\\u003C 2.5 or \\> 4.6 mg\u002Fdl)","Hypo- or hypercalcemia (serum calcium \\\u003C 8.4 or \\> 10.7 mg\u002Fdl)","Severe anemia (hemoglobin \\\u003C 8 g\u002Fdl for women and \\\u003C 9 g\u002Fdl for men)","Severe hyperglycemia (serum blood glucose \\> 300 mg\u002Fdl)","Body weight less than \\\u003C110 lbs (due to risk for phlebotomy-induced anemia)","Received a blood transfusion in the last four months","Extreme hypertension as demonstrated by a blood pressure \\> 180\u002F120 as the average of 3 blood pressures taken during the screening\u002Fbaseline, or extremely low blood pressure \\\u003C 80\u002F50","Unwilling or unable to eat study meals","Lack of access to a functional refrigerator or freezer","Lack of access to a microwave or conventional oven","On low potassium diet","On low phosphate diet","Specific dietary restrictions (i.e. vegetarian, vegan, ketogenic, etc.)","Food allergies including but not limited to milk, egg, soy, nuts, shellfish, and wheat or gluten","Allergic to sodium phosphate","Unable or unwilling to complete urinary sample collection or food diaries","Unable or unwilling to provide informed consent","Unable to read or speak English","Participant in other conflict clinical trial","Unable to complete the study measurements","Unsafe to participate in this study per investigator's judgement","Inclusion Criteria:\n\n* Men or women aged 18 years or older, of any race\u002Fethnicity\n* Women must either be post-menopausal or have no monthly menstrual cycle\n* Estimated total daily energy expenditure (TDEE) of 1700 - 2700 calories\n* eGFR \\>15 ml\u002Fmin\u002F1.73m2 - \\\u003C 60 ml\u002Fmin\u002F1.73m2 for the CKD group (CKD Stage 3 or Stage 4)\n* eGFR ≥ 60 ml\u002Fmin\u002F1.73m2 and negative urine protein on dipstick test for the non-CKD group\n* English speaking\n\nExclusion Criteria:\n\n* Pregnant, currently breastfeeding, or \\\u003C3 months postpartum\n* Current dialysis or kidney transplant patient\n* Current use of insulin or chemotherapy drugs\n* Smokes cigarettes or uses e-cigarettes (vapes)\n* Uses nicotine products or other recreational drugs\n* Medical history of stroke or myocardial infarction (MI)\n* Medical history of conditions that can affect phosphate metabolism (i.e., uncontrolled thyroid disorder, parathyroid disorder, or gastrointestinal malabsorption disorders \\[Crohn's, ulcerative colitis, and celiac disease\\], cirrhosis)\n* Current use of certain medications that directly alter phosphate levels (i.e., phosphate binders; phosphate supplements, irregular use of iron)\n* Regular use of laxatives\n* Hypo- or hyperphosphatemia (serum phosphate \\\u003C 2.5 or \\> 4.6 mg\u002Fdl)\n* Hypo- or hypercalcemia (serum calcium \\\u003C 8.4 or \\> 10.7 mg\u002Fdl)\n* Severe anemia (hemoglobin \\\u003C 8 g\u002Fdl for women and \\\u003C 9 g\u002Fdl for men)\n* Severe hyperglycemia (serum blood glucose \\> 300 mg\u002Fdl)\n* Body weight less than \\\u003C110 lbs (due to risk for phlebotomy-induced anemia)\n* Received a blood transfusion in the last four months\n* Extreme hypertension as demonstrated by a blood pressure \\> 180\u002F120 as the average of 3 blood pressures taken during the screening\u002Fbaseline, or extremely low blood pressure \\\u003C 80\u002F50\n* Unwilling or unable to eat study meals\n* Lack of access to a functional refrigerator or freezer\n* Lack of access to a microwave or conventional oven\n* On low potassium diet\n* On low phosphate diet\n* Specific dietary restrictions (i.e. vegetarian, vegan, ketogenic, etc.)\n* Food allergies including but not limited to milk, egg, soy, nuts, shellfish, and wheat or gluten\n* Allergic to sodium phosphate\n* Unable or unwilling to complete urinary sample collection or food diaries\n* Unable or unwilling to provide informed consent\n* Unable to read or speak English\n* Participant in other conflict clinical trial\n* Unable to complete the study measurements\n* Unsafe to participate in this study per investigator's judgement",[124,125],"ADULT","OLDER_ADULT",[127],{"facility":13,"status":8,"city":128,"state":129,"zip":130,"country":131,"contacts":132,"geoPoint":145},"Dallas","Texas","75390","United States",[133,138,142],{"name":134,"role":135,"phone":136,"email":137},"Alexandra Hartman","CONTACT","2146458294","pack.utsw@utsouthwestern.edu",{"name":139,"role":135,"phone":140,"email":141},"Paola Lanza, MD","469-852-9550","paola.lanza@utsouthwestern.edu",{"name":143,"role":144},"Jing Chen, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":146,"lon":147},32.78306,-96.80667,[149,151],{"name":134,"role":135,"phone":150,"email":137},"214-645-8294",{"name":139,"role":135,"phone":140,"email":141},[153],{"name":154,"affiliation":13,"role":144},"Jing Chen, MD",[],[],{"nct_id":4,"conditions":158,"biomarkers":161},[159,160],"Chronic Kidney Disease","Healthy",[],{"nct_id":4,"found":82,"summary":163,"prompt_version":172},{"design":164,"status":165,"heading":6,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is an interventional study planning to enroll 60 participants, with 30 having CKD and 30 without CKD. It involves a 21-day dietary intervention with increasing phosphorus intake.","completed","This study is looking at how different levels of phosphorus in your diet affect people with Chronic Kidney Disease (CKD) Stages 3-4. Researchers want to understand how your body handles phosphorus and find new ways to measure if you have too much of it. You would follow a special diet for 21 days where the amount of phosphorus you eat gradually increases. The study will measure your blood phosphate, parathyroid hormone (PTH), and FGF23 levels to see how they change. This study is for men and women aged 18 or older with CKD Stage 3 or 4, meaning your eGFR (a measure of kidney function) is between 15 and 60.","Your blood and urine levels will be measured at baseline, week 1, week 2, and week 3, which is the end of the dietary intervention.",110,"You would follow a special diet for 21 days, with phosphorus intake changing weekly. You would have overnight fasting blood and 24-hour and random urine samples collected at the start and end of each week.","Not stated in the trial record.",[],"v2"]