Effect of Dietary Protein Source on Phosphaturia, PTH and FGF23 in Patients With CKD 3 and 4

NCT00764816 | Completed

• 1 other identifier: 0807-03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Phosphorus is a substance in the blood that comes from food and is normally cleared from the body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the body as you eat. This leads to problems with bones and blood vessels over time. In this study, we will compare the blood and urine before and after eating one week of a diet with a protein from plants (soy and grains) and before and after another one week of diet with protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts out in the urine, and the changes in blood hormones in response to the diet will be measured at the beginning and end of each week on the two diets.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease, stages 3 and 4; phosphaturia; phosphorus; PTH; FGF23; Dietary protein source

Outcome Measures

Primary Outcomes (1)

• To determine if the dietary protein source affects fasting serum and urinary phosphorus excretion in patients with CKD stages 3 and 4.

  6 months after baseline

Secondary Outcomes (2)

• To determine if the protein source affects post prandial changes in serum and urinary phosphorus in patients with CKD stages 3 and 4.

  6 months from baseline

• To determine if changes in plasma FGF23 and PTH correlate with urinary phosphorus excretion in response to different protein sources in patients with CKD stages 3 and 4.

  6 months from baseline

Study Arms (2)

1 grain (soy) protein diet:

ACTIVE COMPARATOR

The patient is to eat a grain (soy) protein diet for 7 days. The food is prepared by a registered dietitian.

Other: grain (soy) protein diet

2 casein (meat) protein diet

ACTIVE COMPARATOR

The patient is to eat a casein (meat) protein diet for 7 days. The food is prepared by a registered dietitian.

Other: casein (meat) protein diet

Interventions

grain (soy) protein diet OTHER

The patient is to eat a grain (soy) protein diet for 7 days. The food is prepared by a registered dietitian.

1 grain (soy) protein diet:

casein (meat) protein diet OTHER

The patient is to eat a casein (meat) protein diet for 7 days. The food is prepared by a registered dietitian.

2 casein (meat) protein diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years
• eGFR 20-45 by modified MDRD equation
• protein/creatinine ratio \<5
• blood pressure \<150/95
• not taking calcium binder or supplements, vitamin D, or phosphate binders
• normal serum phosphorus and calcium corrected for albumin and intact PTH \<100pg/ml
• medically stable
• able to give informed consent and come for all visits

You may not qualify if:

• history of significant liver disease or cirrhosis
• medically unstable
• unable to tolerate diets

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Moe SM, Zidehsarai MP, Chambers MA, Jackman LA, Radcliffe JS, Trevino LL, Donahue SE, Asplin JR. Vegetarian compared with meat dietary protein source and phosphorus homeostasis in chronic kidney disease. Clin J Am Soc Nephrol. 2011 Feb;6(2):257-64. doi: 10.2215/CJN.05040610. Epub 2010 Dec 23.

  PMID: 21183586 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypophosphatemia, Familial

Interventions

Edible Grain; Caseins; Meat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Tubular Transport, Inborn Errors; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypophosphatemia; Phosphorus Metabolism Disorders

Intervention Hierarchy (Ancestors)

Crops, Agricultural; Food; Diet, Food, and Nutrition; Physiological Phenomena; Seeds; Food and Beverages; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Officials

• Sharon M Moe, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

US (1)