High Calcium/Low Phosphorus Diet for Chronic Kidney Disease (CKD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Indiana CTSI CRC, Indianapolis, IN
Chronic Kidney Disease (CKD)+7 More
High Calcium/Low Phosphorus Diet - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a method can be developed to measure calcium and phosphorus balance in patients with chronic kidney disease.

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Eligible Conditions

  • Chronic Kidney Disease (CKD)
  • Phosphorus and Calcium Disorders
  • Chronic Kidney Disease Mineral and Bone Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether High Calcium/Low Phosphorus Diet will improve 6 primary outcomes and 6 secondary outcomes in patients with Chronic Kidney Disease (CKD). Measurement will happen over the course of 2 weeks.

2 weeks
Calcium balance
Calcium kinetic model
Phosphorus balance
Phosphorus kinetic model
24 hours, Day 8
Creatinine clearance rate
48 hours
Fractional calcium absorption
Fractional phosphorus absorption
Day 1, Day 8
Plasma 1,25-dihydroxyvitamin D concentration
Plasma calcium concentration
Plasma fibroblast growth factor 23 concentration
Plasma parathyroid hormone concentration
Plasma phosphate concentration

Trial Safety

Trial Design

2 Treatment Groups

Sequence B
1 of 2
Sequence A
1 of 2
Experimental Treatment

This trial requires 3 total participants across 2 different treatment groups

This trial involves 2 different treatments. High Calcium/Low Phosphorus Diet is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Sequence BLow Ca/Low Phos crossover to Low Ca/High Phos
Sequence ALow Ca/High Phos crossover to Low Ca/Low Phos

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours, day 8
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 hours, day 8 for reporting.

Closest Location

Indiana CTSI CRC - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What are common treatments for kidney diseases?

"Patients with proteinuria, or protein to creatinine ratio > 33 % or blood in urine, require more urgent medical attention due to its high-grade manifestations. More importantly, patients who had proteinuria/protein to creatinine ratio > 33 % should be monitored closely because of the risk of renal decompensation and kidney failure. If proteinuria develops in patients with diabetes nephropathy, urgent medical attention should be initiated." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney diseases?

"Although there are many possible signs and symptoms of kidney diseases, they may first present with milder and less obvious symptoms when a patient first visits a nephrologist. These first symptoms include fatigue, weakness, and weight loss. The best way to look for these symptoms is to ask patient's about their health habits as a way to assess their risk factors. Some signs that nephrolologists check for on a patient are: blood pressure, body weight, and urine type. The patient's doctor is also interested in the number and type of drugs the patient uses. More serious signs may be: kidney failure, leg swelling for unknown reasons, or unexplained protein loss in the urine." - Anonymous Online Contributor

Unverified Answer

What causes kidney diseases?

"Most kidney diseases are of a genetic or developmental nature. The most common causes are genetic diseases, and the majority of renal diseases are primary or secondary to an underlying genetic condition." - Anonymous Online Contributor

Unverified Answer

What is kidney diseases?

"Kidney diseases are disorders of the kidney that are the result of disease, injury, or environmental factors. Because of their varied etiology and presentation, they are treated in a variety of ways." - Anonymous Online Contributor

Unverified Answer

How many people get kidney diseases a year in the United States?

"Approximately 18 million kidney disease-free-Americans have some kidney disease during the year, but less than 3% of these people are diagnosed with kidney disease. We found no evidence that people with a lower level of education or poverty had more kidney diseases. Kidney disease is commonly treated without a diagnosis. There is an urgent medical need for improvement in early recognition of kidney diseases that could be improved by a national public health initiative." - Anonymous Online Contributor

Unverified Answer

Can kidney diseases be cured?

"Dialysis and kidney transplants are effective treatments for patients with severe acute or chronic kidney diseases, but kidney transplantation is still used only with selected patients with chronic kidney diseases and severe acute kidney diseases." - Anonymous Online Contributor

Unverified Answer

Has low calcium/high phosphorus diet proven to be more effective than a placebo?

"On the basis of the results shown in this study, a low calcium/high phosphorus diet was found to be effective in correcting biochemical parameters in the CKD patients with HcP in Iran." - Anonymous Online Contributor

Unverified Answer

Does kidney diseases run in families?

"Genetic risk factors for CKD are present in most families, regardless of the degree of renal disease in the patient examined. Kidney disease in a familial pattern can be inherited separately from a primary renal disease, as evidenced by the high concordance rate between relatives for CRI and ESRD. Whether this familial pattern is a marker of the primary renal disease, or whether both genes can be inherited, remains to be established." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving low calcium/high phosphorus diet?

"Low calcium/high phosphorus diet and other diets can be used to decrease the P and Ca absorption and consequently decrease the level of HPT and increased P synthesis in hyperparathyroidism." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in low calcium/high phosphorus diet for therapeutic use?

"The use of low calcium diet by peritoneal dialysis patients is not common and its effectiveness is doubtful. However, its use is gaining increasing acceptance under some circumstances, when the patient cannot tolerate large amounts or frequent administrations of calcium citrate with a high dose of phosphate. In addition to its effectiveness and tolerability, calcium diet has the further advantage that it is also associated in many instances with a rapid improvement of hyperparathyroidism. Thus, it is proposed that low calcium diet by peritoneal dialysis should be reconsidered as its use becomes a viable alternative to calcium citrate, by peritoneal dialysis patients." - Anonymous Online Contributor

Unverified Answer

What is the latest research for kidney diseases?

"A recent review of emerging clinical trials of kidney diseases has highlighted the importance of using the term 'emergency' to refer to the time to treatment of kidney diseases. Clinical trial design must include consideration of an individual patient's risk and likelihood of benefit, with timing of treatment being key to success of the study." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of kidney diseases?

"In a recent study, findings revealed that kidney diseases are significantly more common in young patients than old patients. This finding suggests that kidney diseases may have a primary (non-genetic) cause, and that genetic or other environmental factors must play a secondary pivotal role." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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