Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in Peritoneal Dialysis (PD) Patients

NCT00633646 | Completed

• 1 other identifier: 05PJ14057(Shanghai, China)
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.

Conditions

Chronic Kidney Disease; Peritoneal Dialysis

Keywords

nitrogen balance; malnutrition; chronic kidney disease; diet; glomerular filtration rate

Outcome Measures

Primary Outcomes (1)

• nitrogen balance,residual renal function and nutritional status

  10 day and 1 year

Study Arms (3)

1

ACTIVE COMPARATOR

low protein diet

Dietary Supplement: diets contained different levels of protein

2

ACTIVE COMPARATOR

low protein diet with keto acids

Dietary Supplement: diets contained different levels of protein

3

ACTIVE COMPARATOR

high protein diet

Dietary Supplement: diets contained different levels of protein

Interventions

diets contained different levels of protein DIETARY_SUPPLEMENT

diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d

Also known as: LP, sLP, HP

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 years
• stable peritoneal dialysis since at least 1 month
• with renal function

You may not qualify if:

• a high probability (assessed by the recruiting physician) of receiving a kidney transplant within one year
• overt infection within the last month
• poor compliance in previous dietary prescriptions or irregular check-ups
• persistent anorexia, vomiting or diarrhea within the last month
• a CRP of more than 30 mg/dL
• presence of wasting diseases such as cancer or tuberculosis

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Malnutrition

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; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Yao Qiang, MD, Ph.D

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 12, 2008
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: April 28, 2008

Record last verified: 2008-03