Investigating the effect of an ultra dose of vitamin D₃ in the amount of 10000 IU/Kg orally and comparing it with the usual dose of vitamin D₃ in the amount of 2000 IU orally daily on clinical and laboratory outcomes in critical children hospitalized in PICU.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 237 patients. To randomize from the table of random numbers using www.randomization.com
Settings and conduct
The study was conducted in Akbar Children's Hospital of Mashhad. The patient and the attending physician remained unaware of the method of randomization and placement of the patient in the assigned treatment group.
92 children without vitamin D deficiency (group-A) and 98 children with insufficient/low vitamin D (group-B) were examined. One group of B-group children were treated with normal dose (B1-group) and the other group with ultradose (B2-group) of vitamin D₃. Then the groups were examined in terms of laboratory factors on the first and seventh days and clinical outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Critically ill children admitted to the pediatric intensive care unit
healthy children
Exclusion criteria:
History of kidney failure
History of liver diseases
sepsis
AIDS disease
Hemodynamic instability
Lack of enteral feeding
Patients with hypercalcemia
Patients with intestinal malabsorption
Cystic fibrosis patients
Intervention groups
One group ultra dose of vitamin D3 in the amount of 100,000 oral units and in the group of vitamin D3 with a standard dose (400 units)
Main outcome variables
vitamin D; Calcium; phosphorus; PTH; alkaline phosphatase; AST; ALT; non-fasting blood sugar; urea; Creatinine; albumin; hemoglobin; WBC; percentage of neutrophils and lymphocytes; NLR; CRP; GFR; Urinary calcium and creatinine.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221129056657N1
Registration date:2023-01-17, 1401/10/27
Registration timing:retrospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Gholamreza khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3189 1780
Email address
khademigh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2020-04-20, 1399/02/01
Trial completion date
2020-04-20, 1399/02/01
Scientific title
Evaluation of the effect of ultra-dose of vitamin D₃ as 10000 IU/Kg on clinical and laboratory results of critical children admitted to PICU
Public title
The effect of ultra-dose of vitamin D₃ on critical children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of one month to 18 years Healthy children
Critically ill children admitted to the PICU
Healthy children
Exclusion criteria:
Chronic kidney disease and nephritic syndrome
Severe parenchymal or obstructive liver disease
Vitamin D-dependent rickets type B1 (VDDR-1B) and type A1 (VDDR-1A)
Hereditary vitamin D resistant rickets (HVDRR)
High-dose glucocorticoid treatment
AIDS treated with antiretroviral drugs
Patients treated with phenytoin, phenobarbital, carbamazepine, isoniazid, theophylline and high doses of glucocorticoid
Lack of oral or enteral nutrition
Patients with hypercalcemia, intestinal malabsorption such as celiac disease and IBD, exocrine pancreatic disorder such as cystic fibrosis
History of bowel resection or bariatric surgery
Suffering from a chronic disease or current severe disease (in outpatients)
Age
From 1 month old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
138
Actual sample size reached:
237
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization
Random number table randomization tool using www.randomization.com
Allocation Concealment method: envelopes
closed
In this method, first, a random sequence is created, then based on the size of the research sample, a number of envelopes with aluminum wrappers (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the generated random sequences is recorded on a card, and the cards are inside The letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to perform blinding, ICU nurses, ICU doctors, the patient's treating physician, laboratory experts, statistical consultant,s and data analysts remained unaware of the method of randomization and placement of the patient in the assigned treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Akbar hospital, Kaveh Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Approval date
2019-04-17, 1398/01/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.761
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency in critically ill children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
C-reactive protein factor
Timepoint
on the first day of the study and the seventh day after the intervention
Method of measurement
Taking blood samples and laboratory kits
2
Description
Length of hospitalization in the intensive care unit
Timepoint
On the seventh day after the intervention
Method of measurement
Refer to the patient file
Secondary outcomes
1
Description
Percentage of possible mortality
Timepoint
First day of study
Method of measurement
Completing the Prism form
2
Description
Duration of hospitalization
Timepoint
The seventh day after the start of the intervention
Method of measurement
Complete the checklist
3
Description
Duration of intubation
Timepoint
The seventh day after the start of the intervention
Method of measurement
Complete the checklist
4
Description
Vitamin D levels
Timepoint
The first day of the study and the seventh day after the start of the intervention
Method of measurement
Using the ELISA laboratory kit (Enzyme-linked immuno_sorbent assay)
Intervention groups
1
Description
The usual dose of vitamin D₃ is 2000 IU orally (gavage), once a day, for 7 days - manufactured by Zahrawi Pharmaceutical Company, Tabriz
Category
Treatment - Drugs
2
Description
Ultra dose of vitamin D₃ in the amount of 10000 IU/Kg orally (gavage) (maximum IU 400000), once a day, for 7 days, manufactured by Zahrawi Pharmaceutical Company, Tabriz
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Gholamreza Khademi
Street address
Akbar Children's Hospital, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Fax
+98 51 3870 9201
Email
khademigh@mums.ac.ir
Web page address
https://akbar.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
3rd floor, University Research and Technology Vice-Chancellor, University of Medical Sciences, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944 -91388
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant from Mashhad University of Medical Sciences
Grant code / Reference number
IR.MUMS.MEDICAL.REC.1397.761
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Khademi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital, Shahid Kaveh Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
khademigh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Khademi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital-Shahid Kaveh Boulevard - Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3189 1780
Fax
Email
khademigh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Gholamreza Khademi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital-Shahid Kaveh Boulevard - Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3189 1780
Fax
Email
khademigh@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data related to the main outcomes
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
For the purpose of research for the academic community
From where data/document is obtainable
With Dr. Gholamreza Khademi, co-response author
khademigh@mums.ac.ir
What processes are involved for a request to access data/document
Request via email to Dr. Gholamreza Khademi
After the correspondence, the data will be sent about two weeks after the registration of the request.