Recruiting

Phosphate Metabolism

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07368946

Conditions

Chronic Kidney Disease (Stage 3-4)

Chronic Kidney Disease Mineral and Bone Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dietary Phosphorus Intake

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Disease (Stage 3-4)

Chronic Kidney Disease Mineral and Bone Disorder

Study ID

NCT07368946

Start date

May 9, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)
  • eGFR ≥ 60 ml/min/1.73m2 and negative urine protein on dipstick test for the non-CKD group
  • English speaking

Exclusion Criteria:

  • 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)
  • 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 < 2.5 or > 4.6 mg/dl)
  • Hypo- or hypercalcemia (serum calcium < 8.4 or > 10.7 mg/dl)
  • Severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men)
  • Severe hyperglycemia (serum blood glucose > 300 mg/dl)
  • Body weight less than <110 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 > 180/120 as the average of 3 blood pressures taken during the screening/baseline, or extremely low blood pressure < 80/50
  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Chronic Kidney Disease Patients

Participants with eGFR >15 ml/min/1.73m2 - < 60 ml/min/1.73m2 for the CKD group

active comparator: Control Group

Healthy participants without CKD eGFR ≥ 60 ml/min/1.73m2

Interventions

Dietary Phosphorus Intake

Dietary 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.

Primary outcome measure

  • Change in serum phosphate levels [ Time Frame: Baseline, week 1, week 2, and week 3 ]
  • Change in parathyroid hormone (PTH) levels [ Time Frame: Baseline, week 1, week 2, and week 3 ]
  • Change in C-terminal Fibroblast Growth Factor 23 (FGF23) levels [ Time Frame: Baseline, week 1, week 2, and week 3 ]
  • Change in Fibroblast Growth Factor 23 (FGF23) levels [ Time Frame: Baseline, week 1, week 2, and week 3 ]
  • Phosphate burden indices [ Time Frame: Baseline, week 1, week 2, week 3 ]

Central Contacts and Locations

Central contacts

Alexandra Hartman

214-645-8294pack.utsw@utsouthwestern.edu

Paola Lanza, MD

469-852-9550paola.lanza@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Alexandra Hartman

2146458294pack.utsw@utsouthwestern.edu

Paola Lanza, MD

469-852-9550paola.lanza@utsouthwestern.edu

Principal Investigator:

Jing Chen, MD, PhD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • chronic kidney disease
  • study diet
  • feeding study
  • pilot
  • oral phosphate feeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-01-28.