Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00597025 |
|
Recruitment Status : Unknown
Verified December 2007 by Satellite Healthcare.
Recruitment status was: Recruiting
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
|
Sponsor:
Satellite Healthcare
Information provided by:
Satellite Healthcare
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| End Stage Renal Disease Hypoalbuminemia Malnutrition | Dietary Supplement: Protein Food Bar Intelligent Indulgence | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 375 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin |
| Study Start Date : | December 2007 |
| Estimated Primary Completion Date : | December 2009 |
| Estimated Study Completion Date : | December 2009 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
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. ]
- 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 ]
Secondary Outcome Measures :
- Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period [ Time Frame: Month 3 ]
- 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 ]
- Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored [ Time Frame: Each month for 3 months ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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. |
| Responsible Party: | Brigitte Schiller-Moran, Satellite Healthcare, Inc. |
| ClinicalTrials.gov Identifier: | NCT00597025 History of Changes |
| Other Study ID Numbers: |
SR017PB |
| First Posted: | January 17, 2008 Key Record Dates |
| Last Update Posted: | January 17, 2008 |
| Last Verified: | December 2007 |
Keywords provided by Satellite Healthcare:
|
Malnutrition Hypoalbuminemia Dietary Supplements Hemodialysis Peritoneal Dialysis |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Malnutrition Hypoalbuminemia Renal Insufficiency, Chronic Renal Insufficiency Kidney Diseases |
Urologic Diseases Nutrition Disorders Hypoproteinemia Blood Protein Disorders Hematologic Diseases |