Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07368946

Phosphate Assessment in Chronic Kidney Disease Patients Study

Led by University of Texas Southwestern Medical Center · Updated on 2026-01-28

60

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Phosphate Assessment in Chronic Kidney Disease Patients Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 18 years or older, of any race/ethnicity
  • Women must 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 and < 60 ml/min/1.73m2 for the CKD group (Stage 3 or 4 CKD)
  • eGFR 60 ml/min/1.73m2 and negative urine protein on dipstick test for the non-CKD group
  • English speaking
Not Eligible

You will not qualify if you...

  • Pregnant, currently breastfeeding, or less than 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 affecting phosphate metabolism (uncontrolled thyroid disorder, parathyroid disorder, gastrointestinal malabsorption disorders such as Crohn's, ulcerative colitis, celiac disease, cirrhosis)
  • Current use of medications that alter phosphate levels (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
  • Received a blood transfusion in the last four months
  • Extreme hypertension (blood pressure > 180/120 or < 80/50 averaged across three measurements)
  • 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 (vegetarian, vegan, ketogenic, etc.)
  • Food allergies including milk, egg, soy, nuts, shellfish, 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 conflicting clinical trials
  • Unable to complete study measurements
  • Deemed unsafe to participate by investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

A

Alexandra Hartman

CONTACT

P

Paola Lanza, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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