Effect of Bovine Colostrum on Toxicity and Inflammatory Responses (CALL)
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|ClinicalTrials.gov Identifier: NCT01766804|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Dietary Supplement: Bovine Colostrum Dietary Supplement: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia|
|Actual Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Bovine colostrum
A daily supplement of bovine colostrum powder.
Dietary Supplement: Bovine Colostrum
The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
Other Name: Colodan, Biodane-Pharma.
Placebo Comparator: Placebo
A daily placebo supplement consisting of whole milk powder and whey protein.
Dietary Supplement: placebo
- Days with fever. Fever [ Time Frame: Measured two times daily and on suspicion during the intervention period, up to four weeks, ]Days with temperature at or above 38.5 degrees celsius.
- Days in intensive care unit [ Time Frame: During the 4 week intervention period ]Number of days treated in an intensive care unit.
- Days in i.v. antibiotic treatment. [ Time Frame: During the 4 week intervention period. ]Number of days in intravenous antibiotic treatment during the intervention period.
- Duration of cytopenia (neutrocytes <1,0 and platelets <20) [ Time Frame: During the 4 week intervention period. ]
- Proven or suspected infections [ Time Frame: During the 4 week intervention period ]Episodes of suspected or culture positive sepsis number of documented septic events either culture proven or those treated with a course of antibiotics.
- Number of blood and platelet transfusions given during the course of treatment [ Time Frame: During the 4 week intervention period. ]Number of blood and platelet transfusions given during the course of treatment
- Clinical and paraclinical indices of gastrointestinal toxicity [ Time Frame: At base line and weekly during the 4 week intervention period. Up to 4 weeks. ]
Clinical toxicity is scored using Common Toxicity Criteria for Adverse Effects (NCI-CTCAE), WHO and oral mucositis assessment scale (OMAS) grading schemes at inclusion and weekly during the treatment period. Furthermore the patients register toxicity using the oral mucositis daily questionaire(OMDQ).
Paraclinical indices are citruline, fecal calprotectin,
- Serologic markers for systemic inflammation [ Time Frame: Weekly and at day 3 and 24, up to 4 weeks. ]
Serum will be taken weekly. Markers will include C reactive protein (CRP), procalcitonin (PCT), soluble urokinase plasminogen activator receptor (sUPAR), plasma cytokines and receptors (IL-6, IL-8, Soluble tumour necrosis factor receptors (sTNFR1), IL-1Ra).
Cytokine production in full blood cultures will be measured at day 3 and at day 24. Initial screening for a broad spectrum of cytokines will be performed in 5-10 patients. Based on these results a final panel of analyses comprising a narrower spectrum of cytokines will be determined and used for further investigation. These will include at least TNFR1, IL-1Ra, IL-6, IL-8.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766804
|Copenhagen, Denmark, 2100|
|Odense University Hospital|
|Odense, Denmark, 5000|
|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|