Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

NCT00179153 | Completed Phase 2

• 1 other identifier: 040345
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• increase in serum albumin

  6 months

Study Arms (1)

1

ACTIVE COMPARATOR

Dietary Supplement: Nepro nutritional supplement

Interventions

Nepro nutritional supplement DIETARY_SUPPLEMENT

oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months

1

Eligibility Criteria

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

You may qualify if:

• On CHD dialysis for more than 6 months
• Adequately dialyzed (Kt/V \> 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V \> 1.0 but \< 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study.
• Suboptimal nutritional status identified by one of the following criteria:
• Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months
• Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight.
• Serum albumin less than 4.0 g/dl
• Serum transferrin concentration less than 250 mg/dl
• Serum prealbumin concentration less than 32 mg/dl
• Subjective Global Assessment Score less than 5.

You may not qualify if:

• Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available)
• Refusal to sign a consent form
• On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

National Kidney Foundation

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Study Officials

• Alp Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

US (1)