Investigating the effect of vitamin D in the treatment of fever and neutropenia caused by chemotherapy in children with malignancy
Design
This study will be conducted as a clinical trial. First, the study participants will be selected from among the clients based on the entry criteria
1 to 16 years old with malignancy undergoing chemotherapy who have fever and neutropenia and are in the hematology and oncology department of the hospital
Amirkabir Arak are hospitalized, they are selected. Their vitamin D level is checked. If the patient has vitamin D deficiency (less than 20 ng/ml) or insufficient vitamin D (20 ng/ml), he can participate in the study.
Settings and conduct
Study participants are divided into two groups by permutation block randomization with four blocks and as follows
Randomly, along with routine treatments for fever and neutropenia (ceftazidime and amikacin), group A will be prescribed oral vitamin D drops at a dose of 1000 units daily for two weeks from the first day of hospitalization, and group B will be prescribed routine treatments.
Participants/Inclusion and exclusion criteria
Admitted to the pediatric hematology and oncology department of Amirkabir Arak Hospital, aged 1 to 16 years, with fever and neutropenia.
due to chemotherapy, informed consent of the patient's parents for the child's participation in the study, the initial vitamin D level being lower than the normal level, not taking the vitamin arbitrarily
Intervention groups
Children with malignancy who developed fever and neutropenia during chemotherapy treatment.
Main outcome variables
The rate of response to treatment is checked based on the patient's temperature being below 38.3 degrees Celsius on one occasion or below 38 degrees Celsius on several occasions for more than one hour and the number of peripheral blood neutrophils reaching over 500.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240608062045N1
Registration date:2024-07-22, 1403/05/01
Registration timing:retrospective
Last update:2024-07-22, 1403/05/01
Update count:0
Registration date
2024-07-22, 1403/05/01
Registrant information
Name
Sara Atoufi Najaf Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3421 7233
Email address
dr.atoufi77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2024-05-21, 1403/03/01
Trial completion date
2024-05-21, 1403/03/01
Scientific title
Evaluation of the effect of vitamin D in the treatment of chemotherapy-induced fever and neutropenia in children with malignancy
Public title
the effect of vitamin D in the treatment of chemotherapy-induced fever and neutropenia in children with malignancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pediatric hematology and oncology department of Amirkabir Arak Hospital, aged 1 to 16 years, with fever and neutropenia due to chemotherapy, informed consent of the patient's parents for the child to participate in the study, the initial vitamin D level is lower than the normal level) by the initial vitamin D level test D is measured and values less than 20 ng/ml are considered as deficiency and values of 29 ng/ml are considered as insufficient.) Not taking vitamins arbitrarily
Exclusion criteria:
Age
From 1 year old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
All children were included in the study according to the entry criteria and sampling was done in an easy and accessible way. In this study, in order to randomize into two groups: routine treatment + oral vitamin D drops (group A) and routine treatment (group B). The permutation block randomization method with four blocks will be used. The randomization list will be prepared using the software
Then, based on the order of randomization, the study is carried out to reach the desired sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
Shahid Shiroudi St, Nurse Sq, Amir Kabir Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Approval date
2022-10-09, 1401/07/17
Ethics committee reference number
IR.ARAKMU.REC.1401.210
Health conditions studied
1
Description of health condition studied
Fever and neutropenia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fever and neutropenia
Timepoint
For each patient on the 3rd, 7th, 10th, 14th day, the results are recorded as full treatment, partial treatment or no treatment.
Method of measurement
The level of neutropenia is checked by the CBC test, which is routinely taken every other day from hospitalized patients, and The degree of fever is also recorded by the ward nurse with a thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment group for fever and neutropenia (ceftazidime and amikacin) + vitamin D oral drops with a dose of 1000 units daily for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Sara Atoufi Najaf Abadi
Street address
Shahid shiroudi St, Nurse Sq, Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3133 5147
Email
amirkabir_hospital@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahdi Salehi
Street address
Basij sq, arak medical sciences university complex
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3507
Email
salehi58@gmail.com
Web page address
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
sara atoufi najaf abadi
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Basij sq, arak medical sciences university complex
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3507
Email
dr.atoufi77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
sara atoufi najaf abadi
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Basij Sq, Arak Medical Sciences University Complex
City
arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3507
Email
dr.atoufi77@gmai.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
sara atoufi najaf abadi
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Basij Sq, Arak Medical Sciences University Complex
City
arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3507
Email
dr.atoufi77@gmai.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available