Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Satellite Healthcare.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Satellite Healthcare
Information provided by:
Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT00597025
First received: January 8, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
End Stage Renal Disease Hypoalbuminemia Malnutrition |
Dietary Supplement: Protein Food Bar Intelligent Indulgence |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin |
Resource links provided by NLM:
Further study details as provided by Satellite Healthcare:
Primary Outcome Measures:
- 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. [ Time Frame: Each month for the three months. ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Each month for 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Each month for 3 months ] [ Designated as safety issue: No ]
- Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored [ Time Frame: Each month for 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 375 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group A
Center Hemodialysis patients
|
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months
|
|
Active Comparator: Group B
Center hemodialysis patients
|
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Patients 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
|
|
No Intervention: Group C
Center Hemodialysis Patients
|
|
|
Active Comparator: Group D
Peritoneal dialysis patients
|
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.
|
|
No Intervention: Group E
Peritoneal dialysis patients
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597025
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597025
Contacts
| Contact: Brigitte Schiller-Moran, MD | 650-404-3640 | schillerb@satellitehealth.com | |
| Contact: Sheila Doss, RN, CCRA | 650-404-3621 | dosss@satellitehealth.com |
Locations
| United States, California | |
| Satellite Healthcare, Inc. | Recruiting |
| Mountain View, California, United States, 94041 | |
| Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com | |
| Contact: Sheila Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com | |
| Principal Investigator: Brigitte Schiller-Moran, MD | |
| WellBound, Inc. | Recruiting |
| Mountain View, California, United States, 94041 | |
| Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com | |
| Contact: Sheila Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com | |
| Principal Investigator: Brigitte Schiller-Moran, MD | |
Sponsors and Collaborators
Satellite Healthcare
Investigators
| Principal Investigator: | Brigitte Schiller-Moran, MD | Satellite Healthcare, Inc. |
More Information
No publications provided
| Responsible Party: | Brigitte Schiller-Moran, Satellite Healthcare, Inc. |
| ClinicalTrials.gov Identifier: | NCT00597025 History of Changes |
| Other Study ID Numbers: | SR017PB |
| Study First Received: | January 8, 2008 |
| Last Updated: | January 8, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Satellite Healthcare:
|
Malnutrition Hypoalbuminemia Dietary Supplements Hemodialysis Peritoneal Dialysis |
Additional relevant MeSH terms:
|
Hypoalbuminemia Kidney Failure, Chronic Blood Protein Disorders Hematologic Diseases Hypoproteinemia |
Kidney Diseases Renal Insufficiency Renal Insufficiency, Chronic Urologic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015