Protocol summary

Study aim
Choosing the right treatment method to bring the serum vitamin D level to the normal range among preterm neonates
Design
In this study, we have two parallel intervention and control groups that are assigned to treatments by using a block random method using blocks of size 2 (ab and ba). The sample size includes a total of 90 infants, 45 in each group. In this study, the goal is the determination of the effective treatment , therefore, the phase of trial is 3.
Settings and conduct
This study on 90 premature infants will carried on in NICU at Shahid Akbarabadi hospital in Tehran, Iran. No blinding will be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants; with vitamin D deficiency. Non-inclusion criteria: Patients who received vitamin D before the study began; infants with malnutrition; neonates with GFR less than 50; newborns with thyroid disorders.
Intervention groups
Intervention group: Receiving vitamin D by injection. Control group: receiving vitamin D orally.
Main outcome variables
Serum level of Vitamin D

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160120026115N8
Registration date: 2022-02-26, 1400/12/07
Registration timing: registered_while_recruiting

Last update: 2022-02-26, 1400/12/07
Update count: 0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Mandana Kashaki
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 2277
Email address
kashakimd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vitamin D levels after oral and intramascular vitamin D treatment in premature infants with vitamin D deficiency
Public title
Comparison of Intramuscular and Oral Vitamin D Treatment in Preterm Infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All premature infants in the NICU ward Vitamin D level within the range of deficiency.
Exclusion criteria:
Premature infants who received oral or intravenous administration of vitamin D before the start of the study neonates have a malabsorption disease based on clinical presentation neonates with GFR less than 50 neonates with thyroid disorders
Age
From 14 days old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In Simple Random Sampling, each element of the target community has an equal chance of being selected. In this study, we used the sampling method using Excel software. In this way, the numbers 1 to 91 using the command: = Randbetween (1.91) That Randbetween is a variable function. This command was given to the software and the software randomly places these numbers in a column as a table of random and random numbers. Then the first 45 are assigned to the first treatment and the second 45 to the second treatment. Random numbers are the same as the number of people entering the study, which are as follows: Random samples extracted in the first group: (15, 61,68,6,37,41,76,23,81,43,56,13,35,10,60,12,51,28,4,17,71,26,65,38,20 , 33,72,87,82,11, 53,1,91,58,44,85,2,75,67,50,70,45,64,79,46) (48,55,62,36,84,39,49,77,69,47,8,34,22,59,5,83,30,66,52,27,19,73,42,18,9 , 24,80,78,88,40,3,7,32,25,57,31,54,21,74,14,29,63,86,16,90) These numbers are such that the people who enter in numbers 15, 61, 68, etc .; To the first treatment and those who enter 48, 55, 62, etc .; Are assigned to the second treatment. Follow-up of patients on the 16th day after administration of the drug by measurement of vitamin D, calcium, phosphorus and serum alkaline phosphatase. Took
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Shaheed Akbarabadi Hospital, Molavi Street
City
Tehran
Province
Tehran
Postal code
1168743514
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.78

Health conditions studied

1

Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified

Primary outcomes

1

Description
serum level in terms of vitamin D
Timepoint
At the beginning of the study and 14 days after treatment
Method of measurement
Lab tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intramuscular injection of vitamin D( injection 15000 units per day single dose)
Category
Treatment - Drugs

2

Description
Control group: Prescribing oral vitamin D (oral drops of 1000 units, 1ml daily up to 15 Days )
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Abadi hospital
Full name of responsible person
Mandana Kashaki
Street address
Akbar Abadi Hospital, Molavi Ave
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
kashakimd@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Irani
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1494868871
Phone
+98 21 4474 0360
Email
kashakimd@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mandana Kashaki
Position
Neonatologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Molavi
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
kashakimd@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mandana Kashaki
Position
Neonatologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Molavi
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
kashakimd@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mandana Kashaki
Position
Neonatologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Molavi avenue
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 2277
Fax
+98 21 5563 2277
Email
kashakimd@gmail.com

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after making individuals unidentifiable
When the data will become available and for how long
The access period starts one year after the results are published.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data are allowed for further studies on this research topic.
From where data/document is obtainable
Leila Irani/ Iran University of Medical Sciences/ Iran University of Medical Sciences, Hemmat highway/ or Email address: kashakimd@gmail.com
What processes are involved for a request to access data/document
Written request or email
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