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Trial record 16 of 493 for:    Supplement | maltodextrin

A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03019250
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ghazaleh Eslamian, National Nutrition and Food Technology Institute

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 12, 2017
Last Update Posted Date November 12, 2018
Actual Study Start Date  ICMJE January 15, 2017
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
Occurrence of infection [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03019250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • 28-day Mortality [ Time Frame: Day 28 ]
  • 6-month mortality [ Time Frame: month 6 ]
  • Length of stay in ICU [ Time Frame: Day 28 ]
  • Serum Immunity Markers [ Time Frame: baseline, Day 5, Day 10 ]
  • Serum Inflammatory Markers [ Time Frame: baseline, Day 5, Day 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients
Official Title  ICMJE Effects of Colostrum Supplement on Inflammatory and Growth Factors, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Brief Summary Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids, selenium, and antioxidants has been suggested to reduce infections and improve recovery from critical illness. However, the effects of colostrum on clinical outcomes in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.
Detailed Description A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. Intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. Patients will be assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Illness
  • Infection Complication
  • Multiple Organ Dysfunction Syndrome
Intervention  ICMJE
  • Dietary Supplement: Colostrum
    Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
    Other Name: Bovine Colostrum
  • Dietary Supplement: Maltodextrin
    Maltodextrin mixed with water given via NG tube Q 4 hours.
Study Arms  ICMJE
  • Experimental: Colostrum
    Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.
    Intervention: Dietary Supplement: Colostrum
  • Placebo Comparator: Maltodextrin
    Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
    Intervention: Dietary Supplement: Maltodextrin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2017)
200
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)
100
Actual Study Completion Date  ICMJE November 7, 2018
Actual Primary Completion Date November 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (>18 years old) admitted to ICU
  • Start of study intervention within 48 hours after ICU admission
  • Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
  • Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

  • Enrollment in a related ICU interventional study
  • Requiring other specific enteral nutrition for medical reason
  • Death or Discharge before 5th day
  • Having any contra-indication to receive enteral nutrition
  • Pregnant patients or lactating with the intent to breastfeed
  • BMI <18 or > 40.0 kg/m2
  • Have life expectancy of <6 mo
  • Patients who are moribund
  • History of allergy or intolerance to the study product components
  • Receiving colostrum during two weeks before start study product
  • Have other reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03019250
Other Study ID Numbers  ICMJE 2016670
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ghazaleh Eslamian, National Nutrition and Food Technology Institute
Study Sponsor  ICMJE National Nutrition and Food Technology Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ghazaleh Eslamian, MS,PhDcandid National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran
PRS Account National Nutrition and Food Technology Institute
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP