Comparing the effects of vitamin D and placebo on the treatment course of neonates, infants, and children with congenital heart disease following corrective heart surgery
To compare the effects of vitamin D and placebo on the treatment course of neonates, infants, and children with congenital heart disease following corrective heart surgery
Design
In this study, 46 eligible pediatric patients with congenital heart disease who are candidates for corrective heart surgery referring to the heart ward of Razi Hospital affiliated with Birjand University of Medical Sciences will be selected. Participants will be assigned non-randomly to intervention and control groups, and each participant will be assigned a code.
Settings and conduct
This single-blinded study will be conducted in the cardiac surgery department of Razi Hospital affiliated with Birjand University of Medical Sciences. Patients in the intervention group will receive oral vitamin D before surgery, and patients in the control group will receive a placebo. The patient's symptoms will be evaluated by the researcher 24 and 48 hours postoperatively. Based on the patient's condition, inotropic drugs will be prescribed.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: Suffering from congenital heart disease; risk adjustment for congenital heart surgery score below 5; age below or equal to 18 years; serum vitamin D level below or equal to 150 nanograms per milliliter. Major exclusion criteria: Vitamin D contraindications and being treated with steroidal drugs.
Intervention groups
Intervention group: Before surgery, 300,000 units of vitamin D will be given orally in the form of six 50,000 unit pearls soaked in water.
Control group: The patients will receive placebo in the form of an oral solution, which is similar in appearance and volume to the vitamin D solution and appropriate for their age group.
Main outcome variables
Inotrope Score; Vasoactive-Inotrope Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033099N6
Registration date:2019-02-09, 1397/11/20
Registration timing:registered_while_recruiting
Last update:2019-02-09, 1397/11/20
Update count:0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of vitamin D and placebo on the treatment course of neonates, infants, and children with congenital heart disease following corrective heart surgery
Public title
Effect of vitamin D on the improvement of infants and children with congenital heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from congenital heart disease
Risk adjustment for congenital heart surgery score below 5
Age below or equal to 18 years
Serum vitamin D level below or equal to 150 nanograms per milliliter
Consent from parent or legal guardian to participate in the study
The patient being candidate for open heart surgery
Exclusion criteria:
Being treated with steroidal drugs
Vitamin D contraindications
Application of cardio-respiratory support device
Contraindications for oral medication
Active cardiopulmonary resuscitation
Age
From 1 day old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The purpose of the study is explained to the participants. However, they are not told into which group of the study they are assigned.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-03-05, 1396/12/14
Ethics committee reference number
IR.BUMS.REC.1397.301
Health conditions studied
1
Description of health condition studied
congenital heart disease
ICD-10 code
Q24.9
ICD-10 code description
Congenital malformation of heart, unspecified
Primary outcomes
1
Description
Vasoactive-Inotrope Score
Timepoint
24 and 48 hours postoperatively
Method of measurement
Vasoactive-Inotrope Score calculation formula
2
Description
Vasoactive-Inotrope Score
Timepoint
24 and 48 hours postoperatively
Method of measurement
Inotrope Score calculation formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Vitamin D): Before surgery, 300,000 units of vitamin D will be given orally in the form of six 50,000 unit pearls soaked in water.
Category
Treatment - Drugs
2
Description
Control group (placebo): The patients will receive placebo in the form of an oral solution, which is similar in appearance and volume to the vitamin D solution and appropriate for their age group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart ward of Razi Hospital
Full name of responsible person
Dr. Emad Askari Jafarabadi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3262 6000
Email
dr.askary@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Emad Askari Jafarabadi
Position
Pediatric diseases assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 0000
Email
dr.askary@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Emad Askari Jafarabadi
Position
Pediatric diseases assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 0000
Email
dr.askary@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3242 0447
Email
roozgar@bums.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
When the paper extracted from the project is published and for six months
To whom data/document is available
readers of the paper
Under which criteria data/document could be used
Research purposes
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document