60 Participants Needed

Dietary Phosphorus for Chronic Kidney Disease

(PACK Trial)

AH
PL
Overseen ByPaola Lanza, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body processes phosphate, a mineral found in many foods, in individuals with chronic kidney disease (CKD). Researchers aim to discover new ways the body handles phosphorus and to develop tools for effectively measuring its levels. The trial will compare phosphate levels in people with CKD to those in healthy individuals. Those managing CKD, with kidney function within specific levels and without major dietary restrictions, might find this trial suitable. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research in phosphate management for CKD.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not use certain medications that directly alter phosphate levels, like phosphate binders or supplements, and irregular use of iron. If you are on these medications, you may need to stop them to participate.

What prior data suggests that dietary phosphorus intake is safe for chronic kidney disease patients?

Research has shown that dietary phosphorus levels can impact health, particularly for individuals with chronic kidney disease (CKD). Impaired kidney function hinders the removal of excess phosphorus, potentially leading to health issues. Some studies suggest that reducing phosphorus intake might lower the risk of heart problems.

This study emphasizes managing dietary phosphorus rather than introducing a new drug or treatment. When done correctly, this approach is generally safe. No specific negative effects have been directly associated with managing dietary phosphorus, provided it is done carefully and with medical guidance.12345

Why are researchers excited about this trial?

Dietary phosphorus intake is unique because it focuses on managing chronic kidney disease (CKD) through diet rather than medication. Most treatments for CKD typically involve medications to control blood pressure and blood sugar or dialysis in advanced stages. Researchers are excited about this approach because it explores how adjusting phosphorus levels in the diet could slow CKD progression naturally, potentially reducing reliance on pharmacological interventions. This method could offer a more holistic and less invasive way to manage CKD, improving patients' quality of life.

What evidence suggests that dietary phosphorus intake might be an effective treatment for chronic kidney disease?

Research has shown that controlling phosphorus intake is important for people with chronic kidney disease (CKD). Many CKD patients struggle to maintain phosphorus levels, leading to health issues. For instance, 93% of patients on dialysis have difficulty keeping recommended phosphorus levels in their blood. Experts recommend reducing dietary phosphorus to help manage these levels, as excess phosphorus can worsen kidney problems. Lowering phosphorus in the diet can improve health for CKD patients. This trial will compare dietary phosphorus intake in CKD patients with a control group of healthy participants. These findings suggest that managing dietary phosphorus effectively aids in handling CKD.56789

Who Is on the Research Team?

JC

Jing Chen, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Chronic Kidney Disease (CKD), including those at risk of kidney failure or renal osteodystrophy. Participants should be interested in how their diet affects their health, specifically phosphate intake.

Inclusion Criteria

Estimated total daily energy expenditure (TDEE) of 1700 - 2700 calories
English speaking
My kidney function is reduced but not severely (Stage 3 or 4 CKD).
See 3 more

Exclusion Criteria

Smokes cigarettes or uses e-cigarettes (vapes)
I don't have uncontrolled thyroid, parathyroid disorders, severe gut issues, or cirrhosis affecting my phosphate levels.
I do not have a working fridge or freezer.
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants undergo a 21-day dietary intervention with varying phosphorus intake levels

3 weeks
Weekly visits for blood and urine sample collection

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dietary Phosphorus Intake

Trial Overview

The study is testing the effects of dietary phosphorus intake on CKD patients. It aims to discover new pathways in phosphate metabolism, identify biomarkers for phosphate overload, and develop a reliable index to measure dietary phosphorus intake.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Chronic Kidney Disease PatientsActive Control1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

Phosphorus and Nutrition in Chronic Kidney Disease - PMC

We report that 74% of CKD pts ingest beverages and if we considere this evidence we can calculate a weekly net positive balance of phosphate of about 2.800 mg.

Academy of Nutrition and Dietetics Commentary on the ...

Commentary on the Phosphorus Recommendation in the KDOQI Clinical Practice Guidelines for Nutrition in CKD: 2020 Update

Phosphorus Management in CKD: A Holistic Approach

One study revealed that 93% of patients on hemodialysis could not maintain a serum phosphorus level below 4.5 mg/dL — the recommended threshold ...

Relationship of dietary phosphate intake with risk of end- ...

KDIGO guidelines recommend dietary phosphate restriction to lower serum phosphate levels in CKD stages 3–5.

Novel Dietary and Pharmacologic Interventions in

Effective phosphorus control is critical because hyperphosphatemia plays a central role in the development of CKD-mineral and bone disorder (CKD ...

Relationship of dietary phosphate intake with risk of end stage ...

There was no association of 24 hour urinary phosphate excretion with risk of ESRD, CVD-, non-CVD- or all-cause mortality. For comparison, higher serum phosphate ...

Phosphorus and Your CKD Diet

When you have chronic kidney disease (CKD), your kidneys cannot remove phosphorus very well. High phosphorus levels can cause damage to your body. Extra ...

High dietary phosphorus intake is associated with all- ...

At amounts <0.35 mg/kcal, higher phosphorus density was associated with lower cardiovascular mortality risk [adjusted HR (95% CI): 0.30 (0.13, 0.73); P = 0.01].

Dietary phosphorus intake and mortality in moderate chronic ...

Higher levels of serum phosphorus was associated with increased risk of mortality in advanced CKD [ 9 , 10 ] as well as hemodialysis patients [ ...