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Effect of Bovine Colostrum on Toxicity and Inflammatory Responses

NCT01766804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-08-01

No results posted yet for this study

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.

Conditions

Interventions

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.

DIETARY_SUPPLEMENT

placebo

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Steffen Husby

    lead OTHER

Principal Investigators

  • Mathias Rathe, MD · University og Southern Denmark

  • Steffen Husby, MD, DMSc · Odense University Hospital

  • Klaus Müller, MD, DMSc · Rigshospitalet, Denmark

  • Peder S Wehner, MD, PhD · Odense University Hospital

  • Per T Sangild, DVSc, DMSc · Department of Human Nutrition, Faculty of Life Science, University of Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766804 on ClinicalTrials.gov