Effects of Dietary Phosphorus Restriction on Calcium and Phosphorus Balance in Chronic Kidney Disease Patients
This study aims to investigate how restricting dietary phosphorus intake affects calcium and phosphorus balance in patients with chronic kidney disease, through analyzing calcium and phosphorus content in urine and stool collections and modeling isotope kinetics in serum and urine.
High Phosphorus Diet
+ Low Phosphorus Diet
Urogenital Diseases+26
+ Avitaminosis
+ Bone Diseases
Basic Science Study
Summary
Study start date: August 31, 2020
Actual date on which the first participant was enrolled.This study focuses on understanding how calcium and phosphorus are processed in the bodies of individuals with moderate Chronic Kidney Disease (CKD). The main aim is to gather preliminary data on how a common dietary restriction of phosphorus impacts calcium and phosphorus balance and movement in these patients. This research is important as it could support a larger future clinical study, potentially improving care for those with CKD. Participants in this study will be assigned to one of two controlled diets: either a low calcium/high phosphorus diet or a low calcium/low phosphorus diet. After a week of following the diet at home, participants will spend a week in the hospital for full balance testing, including a 48-hour calcium and phosphorus absorption test. Following a break, participants will then switch to the other diet. The study measures the balance and absorption of calcium and phosphorus by analyzing their content in complete 24-hour urine and stool collections, and by using kinetic modeling of isotopes after oral and IV administrations. The results could provide valuable insights into dietary management for individuals with CKD.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Men or women, ages 30-75 years old, any race or ethnicity * Moderate chronic kidney disease * 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 nutritional 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 Exclusion Criteria: * Plans to initiate dialysis within 6 months * Hypercalcemia defined as serum calcium \>10.5 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, or bariatric surgery * Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension * Pregnant or breastfeeding * Prescribed a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter Ca and P metabolism within past 30 days
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location