Contact information
Type
Scientific
Primary contact
Dr R.D. Beek, van
ORCID ID
Contact details
Erasmus Medical Center
Sophia Childrens Hospital
Department of Pediatrics
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
r.d.vanbeek@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR477; MEC number 193.291/2000/144 and 114.720/1991/62
Study information
Scientific title
Acronym
Study hypothesis
Intervention with adequate calcium and vitamin D and physical activities will influence BMD and fracture rate in a positive way during and after treatment for childhood ALL.
Ethics approval
Received from local medical ethics committee
Study design
Randomised single blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute Lymphoblastic Leukemia (ALL)
Intervention
Controlled physical activities
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Increase of BMD
Secondary outcome measures
Decrease of fracture rate
Overall trial start date
01/09/2001
Overall trial end date
01/10/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients aged 4-18 with ALL
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Physical handicap
2. Age <3 years
Recruitment start date
01/09/2001
Recruitment end date
01/10/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CB
Netherlands
Sponsor information
Organisation
Erasmus Medical Center, Sophia Children's Oncology Center Rotterdam (KOCR) (Netherlands)
Sponsor details
P.O. Box 2060
Rotterdam
3000 CB
Netherlands
+31 (0)10 4636691
j.dito@erasmusmc.nl
Sponsor type
Not defined
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre, Sophia Children's Oncology Centre, Rotterdam (KOCR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list