MalnutritionNCT00435123
ProStat Supplementation in Dialysis Patients
A study testing Nutritional Supplement ProStat 64 twice a day in people with Malnutrition and ESRD, run by Fresenius Medical Care North America at 6 sites in United States.
Trial summary
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition. Subjects receive either ProStat 64 or Placebo for three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, ESRD
- What is being tested?
- Nutritional Supplement ProStat 64 twice a day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On hemodialysis
- Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V >1.2)
- Patient or next of kin able to sign consent form
- Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.
- Sub-optimal nutritional status identified by one of the four following criteria:
- Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
Show all 13Show fewer
- Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
- Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
- Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
- Serum transferrin concentration less than 225 mg/dl
- Serum prealbumin concentration less than 32 mg/dl
- Patient is able to transfer with minimal or no assistance.
- Not taking a caloric nutritional supplement for the last 30 days (e.g. Nepro, ProStat, Boost,etc).
Who cannot join
- Active auto-immune, inflammatory or infectious disease
- Documented malignancy within the last 12 months
- Patients on unusual dietary restrictions
- Life-expectancy less than 6 months
- Inability to tolerate nutritional supplements
- Patient does not exceed the DEXA machine weight limit.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Midwest Nephrology Associates
City of Saint Peters, Missouri, 63376
Nephrology Associates
Columbus, Mississippi, 39705
Western New England Renal Transplant Associates
Springfield, Massachusetts, 01107
Metro Hypertension & Kidney Center, LLC.
St Louis, Missouri, 63136
Kansas Nephrology Physicians, PA
Wichita, Kansas, 67214
Lankenau Center for Medical Research
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Randomized, Placebo Controlled, Double Blind Study of the Use of a Nutritional Supplement, ProStat-64, in Chronic Hemodialysis Patients With Poor Nutritional Status.
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition. Subjects receive either ProStat 64 or Placebo for three months. At the end of this period, all subjects will receive ProStat-64 for a further 3 months at which time the study is ended. Parameters of nutritional status (lean body mass and serum protein) will be collected at baseline, 3 months and 6 months.
Read the detailed description
Fifty patients identified as having poor nutrition by the following criteria:
- Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.
- one of the four following criteria:
- Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
- Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
- Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
- Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
- Serum transferrin concentration less than 225 mg/dl
- Serum prealbumin concentration less than 32 mg/dl will be randomized to receive either ProStat 64 or placebo for 3 months. At Baseline a Dexa for lean body mass and labs for BUN, creatinine, glucose, serum albumin, prealbumin and C-reactive protein will be drawn. Cholesterol and transferrin will be recorded from the regular monthly labs if available. In addition, a protein catabolic rate will be calculated and a SGA will be completed.
Patients will take the supplement/placebo twice a day. Measurements will be repeated at month 3. At the end of these measurements, all patients will be switched to open label ProStat64 for an additional 3 months. At month 6 all study procedures/labs are repeated and the study is complete.
- Conditions
- Malnutrition, ESRD
- Being tested
- Nutritional Supplement ProStat 64 twice a day, Placebo supplement
- Keywords
- Malnutrition, ESRD, Hemodialysis
- Medical subject headings
- Malnutrition, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Supplement ProStat 64 twice a dayDietary supplement
Placebo supplementDietary supplement
Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients are randomly assigned to receive either Active Comparator (ProStat 64) or placebo for the first 3 months. At the end of this, all patients receive open label ProStat64. Receives: Dietary Supplement: Nutritional Supplement ProStat 64 twice a day |
| B | Placebo comparator | Patients are randomly assigned to Placebo Comparator or Active Comparator (ProStat 64). At the end of 3 months, all patients receive active ProStat 64 Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in visceral protein stores as measured by serum albumin
Measured: 3 months minimum; 6 months max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: Increased use of commercial product; less eligible patients \& poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Nutrition USA, Inc.
- Investigators
- Mark Kaplan, M.D., Principal investigator, Fresenius Medical Care North AmericaAlp Ikizler, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435123
- Sponsor's protocol ID
- 2006002
- Other IDs
- 061201 Vanderbilt IRB
- Status last verified
- Feb 2008
- First submitted
- 12 Feb 2007
- Last updated
- 21 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ikizler TA, Wingard RL, Harvell J, Shyr Y, Hakim RM. Association of morbidity with markers of nutrition and inflammation in chronic hemodialysis patients: a prospective study. Kidney Int. 1999 May;55(5):1945-51. doi: 10.1046/j.1523-1755.1999.00410.x.
PubMed 10231458Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. doi: 10.1038/ki.1996.323.
PubMed 8840260Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x.
PubMed 12164890Pupim LB, Flakoll PJ, Brouillette JR, Levenhagen DK, Hakim RM, Ikizler TA. Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest. 2002 Aug;110(4):483-92. doi: 10.1172/JCI15449.
PubMed 12189242
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double Blind Study of the Use of a Nutritional Supplement, ProStat-64, in Chronic Hemodialysis Patients With Poor Nutritional Status.
- ClinicalTrials.gov ID
- NCT00435123
- Acronym / sponsor ID
- 2006002
- Conditions
- Malnutrition, ESRD
- Keywords
- Malnutrition, ESRD, Hemodialysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Increased use of commercial product; less eligible patients \& poor enrollment.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Collaborators
- Medical Nutrition USA, Inc.
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition. Subjects receive either ProStat 64 or Placebo for three months. At the end of this period, all subjects will receive ProStat-64 for a further 3 months at which time the study is ended. Parameters of nutritional status (lean body mass and serum protein) will be collected at baseline, 3 months and 6 months.
Detailed description
Fifty patients identified as having poor nutrition by the following criteria:
- Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.
- one of the four following criteria:
- Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
- Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
- Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
- Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
- Serum transferrin concentration less than 225 mg/dl
- Serum prealbumin concentration less than 32 mg/dl will be randomized to receive either ProStat 64 or placebo for 3 months. At Baseline a Dexa for lean body mass and labs for BUN, creatinine, glucose, serum albumin, prealbumin and C-reactive protein will be drawn. Cholesterol and transferrin will be recorded from the regular monthly labs if available. In addition, a protein catabolic rate will be calculated and a SGA will be completed.
Patients will take the supplement/placebo twice a day. Measurements will be repeated at month 3. At the end of these measurements, all patients will be switched to open label ProStat64 for an additional 3 months. At month 6 all study procedures/labs are repeated and the study is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: Nutritional Supplement ProStat 64 twice a dayPatients are randomly assigned to receive either Active Comparator (ProStat 64) or placebo for the first 3 months. At the end of this, all patients receive open label ProStat64. |
| B | Placebo comparator | Dietary Supplement: Placebo supplementPatients are randomly assigned to Placebo Comparator or Active Comparator (ProStat 64). At the end of 3 months, all patients receive active ProStat 64 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- On hemodialysis
- Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V >1.2)
- Patient or next of kin able to sign consent form
- Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.
- Sub-optimal nutritional status identified by one of the four following criteria:
Key exclusion criteria (6 listed)
- Active auto-immune, inflammatory or infectious disease
- Documented malignancy within the last 12 months
- Patients on unusual dietary restrictions
- Life-expectancy less than 6 months
- Inability to tolerate nutritional supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Supplement ProStat 64 twice a day | Dietary supplement | A |
| Placebo supplementPatients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months | Dietary supplement | B |
Primary outcome
Increase in visceral protein stores as measured by serum albumin
Time frame: 3 months minimum; 6 months max
Results and safety
The study was stopped early (reason given: Increased use of commercial product; less eligible patients \& poor enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2008.
- Background: PubMed 10231458Ikizler TA, Wingard RL, Harvell J, Shyr Y, Hakim RM. Association of morbidity with markers of nutrition and inflammation in chronic hemodialysis patients: a prospective study. Kidney Int. 1999 May;55(5):1945-51. doi: 10.1046/j.1523-1755.1999.00410.x.
- Background: PubMed 8840260Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. doi: 10.1038/ki.1996.323.
- Background: PubMed 12164890Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x.
- Background: PubMed 12189242Pupim LB, Flakoll PJ, Brouillette JR, Levenhagen DK, Hakim RM, Ikizler TA. Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest. 2002 Aug;110(4):483-92. doi: 10.1172/JCI15449.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Kaplan, M.D. principal investigator
Fresenius Medical Care North America
Alp Ikizler, M.D. principal investigator
Vanderbilt University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement ProStat 64 twice a day in people with Malnutrition and ESRD, run by Fresenius Medical Care North America at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Increased use of commercial product; less eligible patients \& poor enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in visceral protein stores as measured by serum albumin (time frame: 3 months minimum; 6 months max). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00435123, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2008.