Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

July 31, 1998

Primary Completion Date

August 31, 2006

Study Completion Date

August 31, 2006

Conditions
End Stage Renal Disease
Interventions
DIETARY_SUPPLEMENT

nutritional supplement

either oral nutritional formula (Nepro) or intravenous IDPN solution will be administered during hemodialysis; Nepro has a total calorie amount as well as protein, carbohydrate and fat content that are comparable to that of IDPN, and will be provided at four equal amounts with 1-hour intervals throughout the study (150 ml for a total of 600 ml over 4 hours of hemodialysis); IDPN consists of 225 ml of amino acids at a concentration of 15%, 112.5 ml of dextrose at 50% and 112.5 ml of lipids at 20%, will be given at a rate of 150 ml/hr, and will provide 209 kcal/hr

DRUG

recombinant human growth hormone (rcGH)

subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days

BEHAVIORAL

exercise

either dual leg press (3 sets of 8-12 repetitions) beginning 30 minutes prior to hemodialysis, or modified stepper (minimum of 15 minutes up to a maximum of 90 minutes, depending upon the patient's tolerance) beginning 15 minutes post initiation of hemodialysis

Trial Locations (1)

37232

Vanderbilt University, Nashville

All Listed Sponsors
lead

Vanderbilt University

OTHER

NCT00244075 - Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients | Biotech Hunter | Biotech Hunter