Protocol summary

Study aim
The effect of vitamin D supplementation on IGF-1 levels in children with idiopathic short stracture
Design
In the present study, 60 children aged 50 to 10 years with short stature, 30 of whom had vitamin D levels less than 30 ng / dl and the second 30 had normal vitamin D levels, were selected and the first group was treated with vitamin D. In the second group, no intervention is performed. Insulin-like growth factor levels are determined and compared at the beginning and end of the intervention in the two groups.
Settings and conduct
Isfahan Imam Hossein Hospital, children with vitamin D levels less than 29 ng / ml, were treated with 50,000 units of vitamin D supplement per week for 8 weeks. After 3 months of treatment, vitamin D and IGF-1 levels were measured again and the results were recorded along with other patient information in the data collection form.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: idiopathic short stracture, age range 5-10 years, low IGF-1 level, vitamin D level less than 29 ng / ml and parental consent to participate in the study.
Intervention groups
Children with vitamin D levels below 29 ng / ml are treated with 50,000 units of vitamin D supplement per week for 8 weeks. Vitamin D is not recommended for children with vitamin D levels above 30 ng / dL. Vitamin D levels and insulin-like growth factor are measured and compared in two groups at the beginning and end of the study.
Main outcome variables
The present study showed that with the elimination of vitamin D deficiency, the level of IGF-1 increases, so it seems that in children with idiopathic short stracture, eliminating vitamin D deficiency can be effective in eliminating IGF-1 deficiency.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200622047874N1
Registration date: 2021-02-15, 1399/11/27
Registration timing: prospective

Last update: 2021-02-15, 1399/11/27
Update count: 0
Registration date
2021-02-15, 1399/11/27
Registrant information
Name
marjan zareian jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 6557
Email address
zareiian@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on serum level of Insulin-like growth factor 1 in 5-10 years old children with idiopathic short stature
Public title
Effect of vitamin D on improvement of n 5-10 years old children with idiopathic short stracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Idiopathic short stracture Age range 5-10 years Low IGF-1 level Parental consent for interewd to study
Exclusion criteria:
Vitamin D level less than 29 ng / ml
Age
From 5 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients in both groups is done using random allocation software. In the mentioned software, the total number of sample size and the number of groups are entered and the software output includes a list that has randomly distributed the total sample size in two groups according to the number. Patients are distributed in two groups according to the time of referral according to the list.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining permission from the University Medical Ethics Committee, the researcher referred to the endocrinology clinic of Imam Hossein Hospital, found children with inclusion criteria, explained the objectives of the research to the patients' parents, and after obtaining written consent, 5 ml of blood sample. Intravenously will be taken from children to measure 25-hydroxy vitamin D and IGF-1 levels
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan university of medical sciences
Street address
Hezarjareeb
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.MUI.REC.1396.3.283

Health conditions studied

1

Description of health condition studied
Idiopathic Short Stracture
ICD-10 code
R62.52
ICD-10 code description
Idiopathic Short Stracture

Primary outcomes

1

Description
Idiopathic short stracture
Timepoint
Three months
Method of measurement
Vitamin D and IGF-1 levels were measured by blood tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Children with vitamin D levels less than 29 ng / ml will be treated with 50,000 units of vitamin D supplement per week for 8 weeks. Vitamin D and IGF-1 levels will be measured again 3 months after starting treatment
Category
Treatment - Drugs

2

Description
Control group: In this group, routine care measures are performed and no intervention is performed. Only vitamin D levels and insulin-like growth factor were measured at the beginning and end of the study, and the results were compared with the intervention group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Elham Hashemi
Street address
Hezarjareeb
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
hashemielham@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfhan Univerdity of Medical Sciences. Hezar jareeb,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezarjareeb
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
hashemielham@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezarjareeb
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
hashemielham@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezarjareeb
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
hashemielham@yahoo.com

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
The plan belongs to a government agency and cannot be shared.
Study Protocol
No - There is not 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
No - There is not 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
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