Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R.D. Beek, van

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children’s 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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes