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End Stage Renal Disease | Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

End Stage Renal Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

End Stage Renal Disease

Hypoalbuminemia

Malnutrition

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Protein Food Bar Intelligent IndulgencePatients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months

Dietary Supplement:Protein Food Bar Intelligent IndulgencePatients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days

Dietary Supplement:Protein Food Bar Intelligent IndulgencePatients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Group ACenter Hemodialysis patients

Group BCenter hemodialysis patients

Group CCenter Hemodialysis Patients

Group DPeritoneal dialysis patients

Group EPeritoneal dialysis patients

Study Status

Unknown status

Start Date: December 2007

Completed Date: December 2009

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome: Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period

Study sponsors, principal investigator, and references

Principal Investigator: Brigitte Schiller-Moran, MD

Lead Sponsor: Satellite Healthcare

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00597025

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