Clinical trial NCT00597025: Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Official title: Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Hypoalbuminemia
Malnutrition
Keywords: Malnutrition
Hypoalbuminemia
Dietary Supplements
Hemodialysis
Peritoneal Dialysis
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.


Eligibility criteria: Inclusion Criteria:

* Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
* 18 years of age or older.
* Must have a reasonable expectation of remaining on treatment for at least 3 months.
* Must have an average serum albumin of \<3.5 g/dL over the three months prior to entry into the study.
* Must be able to understand and sign the informed consent.
* Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods.

Exclusion Criteria:

* Allergy to protein, milk, nuts or wheat.
* Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry.
* Severe acidosis defined as pre-dialysis serum bicarbonate levels of \<15 mEq/L.
* Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
* Hospitalization for an infectious condition within 4 weeks prior to study entry.
* Planned surgery within the three month study period including planned kidney transplantation.

Primary outcomes:
measure: The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period.
timeFrame: Each month for the three months.
measure: Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate.
timeFrame: Each month for 3 months
Secondary outcomes:
measure: Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period
timeFrame: Month 3
measure: Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars.
timeFrame: Each month for 3 months
measure: Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored
timeFrame: Each month for 3 months
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Satellite Healthcare, Inc.
state: California
city: Mountain View
country: United States
facility: WellBound, Inc.
state: California
Study officials:
affiliation: Satellite Healthcare, Inc.
name: Brigitte Schiller-Moran, MD
role: PRINCIPAL_INVESTIGATOR
References: