Effect of Bovine Colostrum on Toxicity and Inflammatory Responses
CALL
1 other identifier
interventional
62
1 country
2
Brief Summary
The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 11, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 1, 2018
July 1, 2018
3.8 years
January 9, 2013
July 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days with fever. Fever
Days with temperature at or above 38.5 degrees celsius.
Measured two times daily and on suspicion during the intervention period, up to four weeks,
Secondary Outcomes (7)
Days in intensive care unit
During the 4 week intervention period
Days in i.v. antibiotic treatment.
During the 4 week intervention period.
Duration of cytopenia (neutrocytes <1,0 and platelets <20)
During the 4 week intervention period.
Proven or suspected infections
During the 4 week intervention period
Number of blood and platelet transfusions given during the course of treatment
During the 4 week intervention period.
- +2 more secondary outcomes
Study Arms (2)
Bovine colostrum
EXPERIMENTALA daily supplement of bovine colostrum powder.
Placebo
PLACEBO COMPARATORA daily placebo supplement consisting of whole milk powder and whey protein.
Interventions
The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
Eligibility Criteria
You may qualify if:
- Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol
You may not qualify if:
- Milk Allergy
- Lactose intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steffen Husbylead
- University of Southern Denmarkcollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (2)
Rigshospitalet
Copenhagen, 2100, Denmark
Odense University Hospital
Odense, 5000, Denmark
Related Publications (2)
Rathe M, De Pietri S, Wehner PS, Frandsen TL, Grell K, Schmiegelow K, Sangild PT, Husby S, Muller K. Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):337-347. doi: 10.1002/jpen.1528. Epub 2019 Mar 12.
PMID: 30861163DERIVEDShen RL, Pontoppidan PE, Rathe M, Jiang P, Hansen CF, Buddington RK, Heegaard PM, Muller K, Sangild PT. Milk diets influence doxorubicin-induced intestinal toxicity in piglets. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G324-33. doi: 10.1152/ajpgi.00373.2015. Epub 2016 Jul 21.
PMID: 27445347DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathias Rathe, MD
University og Southern Denmark
- STUDY CHAIR
Steffen Husby, MD, DMSc
Odense University Hospital
- STUDY CHAIR
Klaus Müller, MD, DMSc
Rigshospitalet, Denmark
- STUDY CHAIR
Peder S Wehner, MD, PhD
Odense University Hospital
- STUDY CHAIR
Per T Sangild, DVSc, DMSc
Department of Human Nutrition, Faculty of Life Science, University of Copenhagen, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization was computer based in blocks of eight to ensure an equal number of participants in each randomization group. The randomization scheme was generated by using the web site Randomization.com ⟨http://www.randomization.com⟩. The randomization center was located at the same hospital as one of the recruitment sites (OUH). The randomization list was sent directly and exclusively to the research secretariat in charge of treatment allocation. Bovine colostrum or the placebo supplement was provided in identical foil sachets differing only in randomization code. Participants, their treating physicians, and any individual involved in the coordination and implementation of the trial were masked to treatment allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 9, 2013
First Posted
January 11, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 1, 2018
Record last verified: 2018-07