Therapeutic effect of vitamin D on Hashimoto thyroiditis
Design
This clinical trial study has two intervention groups. Which samples are selected by an inhomogeneous method.
Settings and conduct
This clinical trial study was performed on 30 samples that were selected by an inhomogeneous method in patients with thyroid problems referring to Amirkola Children's Hospital Endocrinology Clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients under the age of 18 with diagnosis of Hashimoto thyroiditis based on laboratory findings and ultrasonography.
Exit criteria: Patients with thyroid disease, with or without goiter, with normal levels of antibodies, are excluded.Patients with Hashimoto thyroiditis who were already treated.Patients with thyroid disease with or without goiter have normal levels of autoantibodies.Patients with certain chromosomal syndromes, including Down or Turner.Patients with liver and kidney disease.
Intervention groups
Check and treat low levels of vitamin D.
Main outcome variables
Primary outcome : The therapeutic effects of vitamin D on the level of thyroid autoantibodies in Hashimoto thyroiditis.
Secondary outcomes: The therapeutic effects of vitamin D on reducing thyroid gland in Hashimoto thyroiditis.
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180228038900N1
Registration date:2018-04-16, 1397/01/27
Registration timing:prospective
Last update:2018-04-16, 1397/01/27
Update count:0
Registration date
2018-04-16, 1397/01/27
Registrant information
Name
Morteza Alihanpour Aghamaleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
m.alijanpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of vitamin D on Hashimoto thyroiditis
Public title
Therapeutic effect of vitamin D on Hashimoto thyroiditis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: All patients under the age of 18 with diagnosis of Hashimoto thyroiditis based on laboratory findings and ultrasonography.
Exclusion criteria:
Exit criteria: Patients with thyroid disease, with or without goiter, with normal levels of antibodies, are excluded.Patients with Hashimoto thyroiditis who were already treated.Patients with thyroid disease with or without goiter have normal levels of autoantibodies.Patients with certain chromosomal syndromes, including Down or Turner.Patients with liver and kidney disease.
Age
From 2 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
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 Babol University of Medical Sciences
Street address
Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
MUBABOL.HRI.REC.1396.55
Health conditions studied
1
Description of health condition studied
Hashimoto thyroiditis
ICD-10 code
E20-E35
ICD-10 code description
Disorders of other endocrine glands
Primary outcomes
1
Description
Primary outcome : The therapeutic effects of vitamin D on the level of thyroid autoantibodies in Hashimoto thyroiditis.
Timepoint
Time zero and six months later
Method of measurement
blood test
Secondary outcomes
1
Description
Secondary outcomes: The therapeutic effects of vitamin D on reducing thyroid gland in Hashimoto thyroiditis
Timepoint
Time zero and six months later
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: Low levels of vitamin D treatment: First, check blood levels of vitamin D at levels below 30 ng / ml: 1. Low levels of vitamin D between 20 and 30 ng / ml. Pearl contains 50000 units of vitamin D per week for up to 6 weeks, and then checks the blood levels of vitamin D. If the level of vitamin D is increased to above 30 ng, one pearl of vitamin D is given two months until the end of the design (end of 6 months). 2. Low levels of vitamin D lower than 20 ng / ml: Perl vitamin D is 50,000 units per week for one week to 8 weeks and then checks for vitamin D levels. If vitamin levels rise to above 30 ng / ml, Pearl vitamin D is given every month at the end of the plan. Note: If the level of vitamin D does not increase above 30 ng / ml after 6 to 8 weeks in the group, another course of treatment will be performed as described above, and the blood level of vitamin D will be checked again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children’s Hospital
Full name of responsible person
Morteza Alijanpour aghamaleki
Street address
No 19
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
m.alijanpour@yahoo.com
Web page address
http://amirkola.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Ali Akbar Moghaddamnia
Street address
Ganjafroz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9595
Fax
+98 11 3219 4727
Email
info@mubabol.ac.ir
Web page address
http://research.mubabol.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Morteza Aljanpour Aghamaleki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
m.alijanpour@mubabol.ac.ir
Web page address
http://amirkola.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Morteza Alijanpour Aghamaleki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
m.alijanpour@yahoo.com
Web page address
http://amirkola.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Morteza Alijanpour Aghamaleki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 19, Amirkola Children’s Hospital
City
Babol
Province
Mazandaran
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
m.alijanpour@yahoo.com
Web page address
http://amirkola.mubabol.ac.ir
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