Determining the effect of Vitamin D and oral Calcium on bone density in children with leukemia.
Design
This study is a triple blind controlled clinical trial with parallel group design. The randomization method will be simple randomization.
Each group includes 66 patients. In the intervention group vitamin D and calcium supplements are given in addition to common treatments.
Settings and conduct
This study will be conducted at Amir Kabir Hospital in Arak. For all patients with acute lymphoblastic leukemia (ALL), bone mineral density (BMD) and serum level of ALKP, P, Ca, 25OH D3 will be measured at baseline. Then the patients will randomly enter into two groups. In intervention group, patients receive calcium, 30-40 mg/kg per day and vitamin D, 400 units per day in addition to Chemotherapy and patients in the other group only receive chemotherapy.
Six months after the start of the treatment, BMD and serum markers will be remeasured.
This study is triple blind and clinical care providers, Researchers and Data analyzer will be kept blind to the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with acute lymphoblastic leukemia; being at the age of over 5 years old.
Exclusion criteria: Patients with no compliance with the supplements; Patients with no satisfaction to continue the study؛ no compliance in the use of enteric supplements؛ Patients who don't have bone marrow densitometry.
Intervention groups
Patients are assigned randomly into two groups, and in the intervention group in addition to chemotherapy drugs, we add calcium and vitamin D supplements.
Main outcome variables
Bone mineral density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020715N7
Registration date:2018-06-30, 1397/04/09
Registration timing:registered_while_recruiting
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Aziz Eghbali
Name of organization / entity
دانشگاه علوم پزشکی اراک
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.eghbali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-04, 1397/02/14
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To study the effect of oral calcium and vitamin D3 supplementation on bone mineral density in children with acute lymphoblastic leukemia
Public title
to study the effect of calcium and vitamin D supplementation in children with leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All of the children with acute lymphoblastic leukemia above 5 years old
Exclusion criteria:
Patients with no compliance with using supplements
Patients with no satisfaction to continue the study
No compliance with enteric use of supplements
Not doing bone marrow densitometry
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization.
Randomization tools: Random Numbers table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Care providers will be blind tonthe type of medication
The data analyzer is also blind to the grouping.
The Data and Safety Monitoring Board is also unaware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
38481769411
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.299
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
bone mineral density
Timepoint
in the beginning of the study (before the intervention) and 6 months after the intervention
Method of measurement
Bone Mineral Densitometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to chemotherapy drugs, patients receive 30-40 mg/kg calcium and 400 units per day of vitamin D.
Category
Treatment - Drugs
2
Description
Control group: For the control group members rootine care is done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Aziz Eghbali
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
dr.eghbali@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad arjomandzadegan
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Aziz Eghbali
Position
Faculty, Pediatrics Oncologist
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Amirkabir Hospital, Alamalhoda street, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Fax
+98 86 3313 3193
Email
aziz_eghbali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Aziz Eghbali
Position
Faculty, Pediatrics Oncologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Alamalhoda street, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Fax
+98 86 3313 3193
Email
aziz_eghbali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Aziz Eghbali
Position
Faculty, Pediatrics Oncologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Alamalhoda street, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Fax
+98 86 3313 3193
Email
aziz_eghbali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants information will remain confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available