Trial Outcomes & Findings for The CRISIS Prevention Study (NCT NCT00395161)

NCT ID: NCT00395161

Last Updated: 2013-04-18

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

293 participants

Primary outcome timeframe

48 hours after admission until 5 days after discharged from the PICU

Results posted on

2013-04-18

Participant Flow

Dates of recruitment period: April 2007 - November 2009; Location: Pediatric Intensive Care Unit (PICU)

Patients were stratified according to immunocompromised status prior to randomization.

Participant milestones

Participant milestones
Measure	Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Enteral Whey Protein, IV Saline Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
Overall Study STARTED	149	144
Overall Study COMPLETED	149	144
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The CRISIS Prevention Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Nutriceutical Supplementation n=149 Participants Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=144 Participants Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.	Total n=293 Participants Total of all reporting groups
Age, Categorical <=18 years	149 Participants n=5 Participants	144 Participants n=7 Participants	293 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	7.9 years STANDARD_DEVIATION 5.6 • n=5 Participants	8.4 years STANDARD_DEVIATION 5.9 • n=7 Participants	8.1 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	79 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	65 Participants n=7 Participants	145 Participants n=5 Participants
Region of Enrollment United States	149 participants n=5 Participants	144 participants n=7 Participants	293 participants n=5 Participants
Immune Compromised at Study Entry Immune compromised	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Immune Compromised at Study Entry Immune Competent	135 Participants n=5 Participants	133 Participants n=7 Participants	268 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours after admission until 5 days after discharged from the PICU

Population: Intention to treat analysis of all randomized patients.

Outcome measures

Outcome measures
Measure	Daily Nutriceutical Supplementation n=149 Participants Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=144 Participants Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.	12.1 Days Interval 9.25 to 32.4	13.2 Days Interval 10.8 to The upper limit of the 95% confidence interval for median number of days to event in this arm is not calculable due to an insufficient number of participants reaching the event at the final time point for assessment.

SECONDARY outcome

Timeframe: 48 hours after PICU admission till discharge from PICU

Population: All randomized patients analyzed by intention to treat

Outcome measures

Outcome measures
Measure	Daily Nutriceutical Supplementation n=149 Participants Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=144 Participants Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days	4.99 Mean number of events per 100 study days Interval 4.12 to 5.99	4.83 Mean number of events per 100 study days Interval 4.01 to 5.77

SECONDARY outcome

Timeframe: 48 hours after admission until PICU discharge

Population: All randomized patients per intention to treat analysis

Outcome measures

Outcome measures
Measure	Daily Nutriceutical Supplementation n=149 Participants Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=144 Participants Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
Antibiotic-free Days	1 Days Interval 0.0 to 5.0	2 Days Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: from time of PICU admission till discharge from PICU

Population: All randomized patients (intention to treat analysis)

What is reported is the number of participants with counts qualifying as lymphopenia.

Outcome measures

Outcome measures
Measure	Daily Nutriceutical Supplementation n=149 Participants Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=144 Participants Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)	5 participants	12 participants

SECONDARY outcome

Timeframe: 28 days after admission to the PICU

Population: This safety outcome was analyzed by treatment received, among a total of 284 children who received treatment and had known 28-day status.

Outcome measures

Outcome measures
Measure	Daily Nutriceutical Supplementation n=145 Participants Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=139 Participants Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
All-cause 28-day Mortality Rate.	15 participants	8 participants

Adverse Events

Daily Nutriceutical Supplementation

Serious events: 73 serious events

Other events: 119 other events

Deaths: 0 deaths

Whey Protein

Serious events: 70 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jeri Burr, MS, RN-BC, CCRC

University of Utah

Phone: 801-587-7753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Daily Nutriceutical Supplementation n=148 participants at risk Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=139 participants at risk Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
Cardiac disorders Arrhythmia	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Cardiac disorders Cardiac arrest	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	2.9% 4/139 • Number of events 6 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Cardiac disorders Cardiopulmonary arrest	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	1.4% 2/139 • Number of events 3 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Cardiac disorders Myocardial ischemia	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Cardiac disorders Pericardial effusion	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Congenital, familial and genetic disorders Sickle cell anaemia	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Endocrine disorders Diabetes insipidus	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Eye disorders Cortical blindness	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Abdominal distension	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders GI bleed	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Ischemic colitis	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Pancreatitis	1.4% 2/148 • Number of events 2 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Peritonitis	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Brain death	1.4% 2/148 • Number of events 2 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Fever	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Hyperthermia	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Multiple organ failure	1.4% 2/148 • Number of events 2 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Withdrawal syndrome	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Bacteremia	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Catheter site cellulitis	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Encephalitis viral	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Nosocomial infection	29.1% 43/148 • Number of events 73 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	29.5% 41/139 • Number of events 61 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Sepsis	8.8% 13/148 • Number of events 14 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	14.4% 20/139 • Number of events 29 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Tracheitis	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Urinary tract infection	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Injury, poisoning and procedural complications Subdural haematoma	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Amylase high	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood creatinine increased	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood culture positive	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood potassium decreased	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations CSF WBC increased	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Culture stool positive	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Culture urine positive	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Decreased INR	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.72% 1/139 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Lipase increased	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Oxygen saturation decreased	0.68% 1/148 • Number of events 1 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	0.00% 0/139 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations PCO2 increased	0.00% 0/148 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	1.4% 2/139 • Number of events 2 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.

Other adverse events
Measure	Daily Nutriceutical Supplementation n=148 participants at risk Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.	Whey Protein n=139 participants at risk Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
Cardiac disorders Bradycardia	11.5% 17/148 • Number of events 19 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	10.1% 14/139 • Number of events 15 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Cardiac disorders Tachycardia	7.4% 11/148 • Number of events 12 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	14.4% 20/139 • Number of events 24 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Abdominal distension	5.4% 8/148 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.0% 7/139 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Constipation	14.2% 21/148 • Number of events 21 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	10.8% 15/139 • Number of events 15 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Diarrhea	8.8% 13/148 • Number of events 13 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 13 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Emesis	12.8% 19/148 • Number of events 25 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	12.2% 17/139 • Number of events 22 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Gastrointestinal disorders Vomiting	4.1% 6/148 • Number of events 7 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 10 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Fever	8.8% 13/148 • Number of events 13 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	9.4% 13/139 • Number of events 15 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Blood and lymphatic system disorders Anemia	6.1% 9/148 • Number of events 10 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Blood and lymphatic system disorders Coagulopathy	5.4% 8/148 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	2.9% 4/139 • Number of events 4 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Blood and lymphatic system disorders Leukocytosis	6.8% 10/148 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 10 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Hyperthermia	6.8% 10/148 • Number of events 12 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	6.5% 9/139 • Number of events 14 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Hypothermia	6.8% 10/148 • Number of events 19 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
General disorders Pyrexia	10.8% 16/148 • Number of events 22 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	10.1% 14/139 • Number of events 18 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Nosocomial infection	5.4% 8/148 • Number of events 9 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 13 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Infections and infestations Sepsis	5.4% 8/148 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.0% 7/139 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations BUN increased	7.4% 11/148 • Number of events 12 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 9 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood albumin decreased	2.7% 4/148 • Number of events 4 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood magnesium decreased	10.1% 15/148 • Number of events 16 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood phosphorus decreased	8.8% 13/148 • Number of events 17 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	9.4% 13/139 • Number of events 14 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood potassium decreased	7.4% 11/148 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.9% 11/139 • Number of events 13 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Blood sodium decreased	4.1% 6/148 • Number of events 6 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.0% 7/139 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Hematocrit decreased	8.1% 12/148 • Number of events 13 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 10 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Hemoglobin decreased	8.8% 13/148 • Number of events 14 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.2% 10/139 • Number of events 17 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Lipase increased	8.8% 13/148 • Number of events 14 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	3.6% 5/139 • Number of events 5 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Oxygen saturation decreased	12.2% 18/148 • Number of events 20 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	9.4% 13/139 • Number of events 15 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations PCO2 increased	2.0% 3/148 • Number of events 5 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Investigations Platelets decreased	4.1% 6/148 • Number of events 7 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.0% 7/139 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Acidosis	3.4% 5/148 • Number of events 7 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 9 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hyperglycemia	14.2% 21/148 • Number of events 27 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	13.7% 19/139 • Number of events 21 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hyperkalemia	3.4% 5/148 • Number of events 5 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 10 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hypernatremia	7.4% 11/148 • Number of events 12 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hypocalcemia	2.7% 4/148 • Number of events 5 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 10 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hypokalemia	17.6% 26/148 • Number of events 30 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	19.4% 27/139 • Number of events 41 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hypomagnesemia	3.4% 5/148 • Number of events 6 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.0% 7/139 • Number of events 12 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hyponatremia	4.7% 7/148 • Number of events 8 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	7.9% 11/139 • Number of events 13 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Metabolism and nutrition disorders Hypophosphatemia	3.4% 5/148 • Number of events 5 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 9 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Nervous system disorders Seizure	2.0% 3/148 • Number of events 4 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.0% 7/139 • Number of events 7 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Psychiatric disorders Agitation	12.2% 18/148 • Number of events 18 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	12.9% 18/139 • Number of events 19 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.
Renal and urinary disorders Oliguria	5.4% 8/148 • Number of events 9 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.	5.8% 8/139 • Number of events 11 • Adverse events were collected for 28 days. For adverse events, denominators reflect Safety Population of those patients receiving each treatment. Therefore, denominators are 148 patients receiving Daily Nutriceutical Supplementation and 139 patients receiving Whey Protein.