- Determination of vitamin D supplementation effect on glycemic control in pediatrics with type 1 diabetes
Design
42 patients with type 1 diabetes mellitus aged 1 to 18 years, without control group and without blinding in a clinical trial, phase 3
Settings and conduct
Mofid Hospital Endocrinology and Metabolism Clinic, Tehran
Participants/Inclusion and exclusion criteria
Age range from one to eighteen years; given that the goals of glycemic control vary for different ages, age range is important; type 1 diabetes; having at least one year of type 1 diabetes; vitamin D deficiency.
Intervention groups
Vitamin D administration for children with type 2 diabetes
Main outcome variables
Fasting and non-fasting sugars, daily insulin intake, HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044806N1
Registration date:2020-05-30, 1399/03/10
Registration timing:retrospective
Last update:2020-05-30, 1399/03/10
Update count:0
Registration date
2020-05-30, 1399/03/10
Registrant information
Name
Arezoo Shirzani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2232 1040
Email address
shirzani.arezoo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2019-08-03, 1398/05/12
Trial completion date
2019-09-23, 1398/07/01
Scientific title
The evaluation of the effect of administering of vitamin D on glycemic control in pediatric patients with type1 Diabetes Mellitus
Public title
The evaluation of effect of administration of vitamin D on glycemic index in patient with Diabetes Mellitus type1( DM1)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 1-18 years;
catching Diabetes Mellitus type1;
Having at least one year of type 1 diabetes;
vitamin D deficiency.
Exclusion criteria:
Take vitamin D supplements in the past 6 months
No underlying kidney disease
Patient non-cooperation in clinic follow-up
Age
From 1 year old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Medical School Research - Shahid Beheshti University of Medical Sciences
Street address
Tehran, Quds Town (West), between South Flamak and Zarafshan, Iran Sima St. - Central Office of Ministry of Health and Medical Education, Block A, 13th Floor
City
Tehran
Province
Tehran
Postal code
11111111111
Approval date
2019-07-02, 1398/04/11
Ethics committee reference number
IR.SBMU.MSP.REC.1398.339
Health conditions studied
1
Description of health condition studied
Type 1 diabetes in children
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
HbA1C
Timepoint
At baseline (before intervention) and 3 and 6 months after vitamin D intake
Method of measurement
Laboratory sample
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
At baseline (before intervention) and 3, 6 months after vitamin D intake
Method of measurement
Enzymatic
2
Description
Post prandial blood sugar
Timepoint
At baseline (before intervention) and 3, 6 months after vitamin D intake
Method of measurement
Enzymatic
3
Description
Daily insulin intake
Timepoint
At baseline (before intervention) and 3, 6 months after vitamin D intake
Method of measurement
Enzyme-linked immunosorbent
Intervention groups
1
Description
Intervention group: Vitamin D (cholecalciferol), 50,000 units, weekly for 4-6 weeks from Zahrawei Company and then 1000 units daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid pediatric specialty hospital
Full name of responsible person
Arezoo Shirzani
Street address
Shariati Street
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
info-mch@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahid Beheshti University of Medical Sciences
Street address
Mofid Hospital, shariaty Avenue
City
TEHRAN
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
دکتر آرزو شیرزنی
Position
دانشجو
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
mofid hospital, shariati ave.
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marjan Shakiba
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid hospital, Shariati ave.
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 22227
Email
info-mch@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arezoo Shirzani
Position
student
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Mofid hospital, Shariati ave.
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available