Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Protein Supplementation in Dialysis Patients
Brief Summary: The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and approaches 21% per year. Among the many factors that adversely affects patient outcome is uremic malnutrition, a unique form of deranged nutritional status. It is associated with increased hospitalization and death risk in CHD patients. Several measures have been identified to prevent uremic malnutrition in CHD patients, including efforts to optimize dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures. The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting. In this proposal, we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure.


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: pentoxiphylline, Dietary Supplement: Nepro, Dietary Supplement: anti-inflammatory module (similar to Oxepa) | Arm Label: B; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Nepro, Dietary Supplement: anti-inflammatory module (similar to Oxepa), Drug: Placebo pill imitating pentoxiphylline | Arm Label: C; Type: EXPERIMENTAL; Interventions: Drug: pentoxiphylline, Dietary Supplement: Placebo to imitate Nepro, Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa) | Arm Label: D; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo pill imitating pentoxiphylline, Dietary Supplement: Placebo to imitate Nepro, Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa) | Intervention Type: DRUG; Name: pentoxiphylline; Assigned to Arm(s): A, C | Intervention Type: DIETARY_SUPPLEMENT; Name: Nepro; Assigned to Arm(s): A, B | Intervention Type: DIETARY_SUPPLEMENT; Name: anti-inflammatory module (similar to Oxepa); Assigned to Arm(s): A, B | Intervention Type: DRUG; Name: Placebo pill imitating pentoxiphylline; Assigned to Arm(s): B, D | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo to imitate Nepro; Assigned to Arm(s): C, D | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo to imitate anti-inflammatory module (similar to Oxepa); Assigned to Arm(s): C, D
B: Arm Label: modified carbohydrate drink; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Nepro HP (Abbott Nutrition) | Arm Label: macronutrient matched drink; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) | Arm Label: standard drink; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Fortisip compact 125 ml (Nutricia) | Intervention Type: DIETARY_SUPPLEMENT; Name: Nepro HP (Abbott Nutrition); Assigned to Arm(s): modified carbohydrate drink | Intervention Type: DIETARY_SUPPLEMENT; Name: Fortisip compact protein 125 ml + Calogen 20ml (Nutricia); Assigned to Arm(s): macronutrient matched drink | Intervention Type: DIETARY_SUPPLEMENT; Name: Fortisip compact 125 ml (Nutricia); Assigned to Arm(s): standard drink
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Pro-Stat | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Pro-Stat | Arm Label: 3; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 4; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Pro-Stat; Assigned to Arm(s): 1, 2
D: Arm Label: Usual Care Protocol; Type: OTHER; Interventions: Dietary Supplement: Nutritional Supplement | Arm Label: Intensive Protocol; Type: OTHER; Interventions: Dietary Supplement: Nutritional Supplement | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutritional Supplement; Assigned to Arm(s): Intensive Protocol, Usual Care Protocol

Answer: C