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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00179153

Enrollment

352

Registered

2005-09-15

Start date

2005-02-28

Completion date

2009-05-31

Last updated

2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

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.

Interventions

DIETARY_SUPPLEMENTNepro nutritional supplement

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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: 1. 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 2. 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. 3. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion: 1. Serum albumin less than 4.0 g/dl 2. Serum transferrin concentration less than 250 mg/dl 3. Serum prealbumin concentration less than 32 mg/dl 4. Subjective Global Assessment Score less than 5.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
increase in serum albumin	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026