Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435123
Status:
TERMINATED
Last Update Posted:
2008-02-21
First Post:
2007-02-12
Brief Title:
ProStat Supplementation in Dialysis Patients
Sponsor:
Fresenius Medical Care North America
Organization:
Fresenius Medical Care North America
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Increased use of commercial product less eligible patients poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
1 Average of Serum Albumin for the consecutive two months prior to inclusion 37 gdl and the serum albumin for the previous month is 37 mgdl
2 one of the four following criteria
1 Protein catabolic rate less than 10 gkgd on at least 2 occasions over the past 6 months
2 Progressive unintentional weight loss more than 25 of the initial or ideal body weight andor patients who are less than 90 of Standard Body Weight
3 Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
4 Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements if available over the consecutive two months prior to inclusion
1 Serum transferrin concentration less than 225 mgdl
2 Serum prealbumin concentration less than 32 mgdl
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 supplementplacebo 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 procedureslabs are repeated and the study is complete
1 Average of Serum Albumin for the consecutive two months prior to inclusion 37 gdl and the serum albumin for the previous month is 37 mgdl
2 one of the four following criteria
1 Protein catabolic rate less than 10 gkgd on at least 2 occasions over the past 6 months
2 Progressive unintentional weight loss more than 25 of the initial or ideal body weight andor patients who are less than 90 of Standard Body Weight
3 Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
4 Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements if available over the consecutive two months prior to inclusion
1 Serum transferrin concentration less than 225 mgdl
2 Serum prealbumin concentration less than 32 mgdl
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 supplementplacebo 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 procedureslabs are repeated and the study is complete
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 061201 Vanderbilt IRB | None | None | None |