Research with human participants

Overview of medical research in the Netherlands

Molecular determinants of bone mineral density in children with acute lymphoblastic leukemia and the role of intervention by physical activities and calcium and vitamin D supplement as a preventive strategy.

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON28168

Source

NTR

Brief title

intervention study on BMD in ALL

Health condition

ALL patients included in the ALL9 study.

Sponsors and support

Primary sponsor :
KOCR rotterdam
Source(s) of monetary or material Support :
KOCR

Intervention

Outcome measures

Primary outcome

Increase of BMD.

Secondary outcome

Decrease of fracture rate.

Background summary

The treatment of pediatric ALL results in decrease of BMD and an elevated fracture rate. This study investigates whether intervention with physical activity improves BMD and reduces fracture rate during and after treatment for pediatric ALL.

Study objective

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.

Study design

N/A

Intervention

Controlled physical actievities.

Public
Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatrics,
P.O. Box 2060
R.D. Beek, van
Dr. Molewaterplein 60
Rotterdam 3000 CB
The Netherlands
r.d.vanbeek@erasmusmc.nl
Scientific
Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatrics,
P.O. Box 2060
R.D. Beek, van
Dr. Molewaterplein 60
Rotterdam 3000 CB
The Netherlands
r.d.vanbeek@erasmusmc.nl

Inclusion criteria

Patients 4-18 with ALL, without a physical handicap.

Exclusion criteria

Age < 3 years.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Placebo

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
80
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL437
NTR-old NTR477
Other : MEC nr 193.291/2000/144 and 114.720/1991/62
ISRCTN ISRCTN23173889

Summary results

N/A