ProStat Supplementation in Dialysis Patients

2014-08-27 03:40:10 | BioPortfolio


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.


Fifty patients identified as having poor nutrition by the following criteria:

1. Average of Serum Albumin for the consecutive two months prior to inclusion

2. one of the four following criteria:

1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months

2. 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

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 mg/dl

2. 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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment




Nutritional Supplement ProStat 64 twice a day, Placebo supplement


Kansas Nephrology Physicians, PA
United States




Fresenius Medical Care North America

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:40:10-0400

Clinical Trials [1625 Associated Clinical Trials listed on BioPortfolio]

Preoperative Oral Nutritional Supplement vs Conventional Dietary Advice in Major Gastrointestinal Surgery

Surgical outcome is associated the nutritional status of the patients. Perioperative nutritional supplement for malnutritional patient were recommended. There are several guidelines were r...

The Nutritional Health for the Elderly Research Centre Study (The NHERC Study)

The prevalence of malnutrition among the elderly in Asia is high. The objective of this randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of consuming...

Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly

This is a single- country, interventional, double-arm study involving Chinese Elderly subjects.

DaVita Assessment of Nutritional Supplement Effects (DANSE)

This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients wil...

A Study to See Whether a Nutritional Supplement is Beneficial for Patients With Pancreatic Cancer

This study evaluates a nutritional supplement in the treatment of pancreatic cancer in adults. Half of the participants will receive the nutritional supplement, while the other half will r...

PubMed Articles [2512 Associated PubMed Articles listed on BioPortfolio]

Increasing effort without noticing: A randomized controlled pilot study about the ergogenic placebo effect in endurance athletes and the role of supplement salience.

Previous research shows that endurance performance can be enhanced by placebo ergogenic aids. This study investigates the ergogenic placebo response, which we define as an increase in objective and ph...

Soy protein supplement intake for 12 months has no effect on sexual maturation and may improve nutritional status in pre-pubertal children.

To evaluate the intake of a soy protein-based supplement (SPS) and its effects on the sexual maturation and nutritional status of prepubertal children who consumed it for a year.

Screening and management of malnutrition in internal medicine.

Malnutrition is a common but underestimated condition in the hospital setting. Malnutrition increases in-hospital mortality and complications, and treatment costs. Simple screening tools such as the m...

A Purported Detoxification Supplement Does Not Improve Body Composition, Waist Circumference, Blood Markers, or Gastrointestinal Symptoms in Healthy Adult Females.

Numerous popular "detoxification" supplements claim to promote the removal of harmful compounds from the body, thereby alleviating gastrointestinal symptoms, improving body composition, and enhancing ...

Pre- and post-natal macronutrient supplementation for HIV-positive women in Tanzania: Effects on infant birth weight and HIV transmission.

To determine if a protein-calorie supplement (PCS) plus a micronutrient supplement (MNS) improves outcomes for HIV-infected lactating women and their infants.

Medical and Biotech [MESH] Definitions

A genus of filamentous CYANOBACTERIA found in most lakes and ponds. It has been used as a nutritional supplement particularly due to its high protein content.

A species of green microalgae in the family Chlorellaceae. It is used as a model organism for PHOTOSYNTHESIS, and as a food supplement (DIETARY SUPPLEMENTS).

A compound forming white, odorless deliquescent crystals and used as iodine supplement, expectorant or in its radioactive (I-131) form as an diagnostic aid, particularly for thyroid function tests.

A species of the genus SACCHAROMYCES, family Saccharomycetaceae, order Saccharomycetales, known as "baker's" or "brewer's" yeast. The dried form is used as a dietary supplement.

Used as feed supplement for sheep and cattle since it is a good non-protein nitrogen source. In strongly alkaline solution biuret gives a violet color with copper sulfate.

More From BioPortfolio on "ProStat Supplementation in Dialysis Patients"

Quick Search


Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Searches Linking to this Trial