Evaluation of the effect of vitamin D intake on AntiTPO levels in hypothyroid and euthyroid patients with anti-TPO positive.
Design
Interventional clinical trial without a control group, with parallel groups, non-random, without blinding on 128 patients
Settings and conduct
An intervention study in which patients with AntiTPO positive and vitamin D deficiency receive vitamin D supplementation and serum AntiTPO levels of patients are measured 3and6 months later. Patients referred to the ....laboratory are included in the study through
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of both sexes who have AntiTPO positive and their disease is approved by an endocrinologist and are in the age range of 18 to 65 years.
no entry criteria: Patients who have evidence of any disease that affects the immune system balance, such as those with type 1 diabetes, multiple sclerosis, inflammatory bowel disease, and other autoimmune diseases. Those with impaired liver enzymes There are patients with malnutrition, patients with a BMI of less than 18 or more than 40. Patients with hyperthyroidism and a decrease in TSH.
Intervention groups
Intervention group1: Patients who are Anti-TPO positive and have elevated TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng /ml.
Intervention group2: Patients who are anti-TPO positive and have elevated TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml.
Intervention group3: Patients who are anti-TPO positive and have normal TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng/ml.
Intervention group4: Patients who are anti-TPO positive and have normal TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml.
Main outcome variables
Serum levels of Anti TPO before and after taking vitamin D.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210802052054N1
Registration date:2022-05-14, 1401/02/24
Registration timing:registered_while_recruiting
Last update:2022-05-14, 1401/02/24
Update count:0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Sima Shahmohammadi-farid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 3888
Email address
shahmohammadis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-14, 1401/02/24
Expected recruitment end date
2022-11-15, 1401/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D intake on AntiTPO levels in hypothyroid and euthyroid patients with anti-TPO positive: an interventional study
Public title
Evaluation of the effect of vitamin D consumption on the AntiTPO
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both sexes who have AntiTPO positive and their disease is approved by an endocrinologist and are in the age range of 18 to 65 years.
Exclusion criteria:
Patients who have evidence of any disease that affects the balance of the immune system, such as those with type 1 diabetes, multiple sclerosis, inflammatory bowel disease, and other autoimmune diseases.
Patients with impaired liver enzyme function
Malnourished patients
Patients with a BMI of less than 18 or more than 40.
Patients with hyperthyroidism and decreased TSH levels.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
N/A
Randomization description
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 Tabriz University of Medical sciences
Street address
Central Office of Tabriz University of Medical Sciences Tabriz -Golghasht St.- Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-09-13, 1400/06/22
Ethics committee reference number
IR.TBZMED.REC.1400.568
Health conditions studied
1
Description of health condition studied
Autoimmune Hypothyroidism
ICD-10 code
E06.3
ICD-10 code description
Autoimmune thyroiditis
Primary outcomes
1
Description
Serum levels of Anti TPO before and after taking vitamin D.
Timepoint
Anti TPO levels are measured before the intervention and 3 and 6 months after the start of vitamin D intake.
Method of measurement
After starting the study, blood samples are taken from the patients and the patients' serum is removed. Using special Anti TPO kits, the level of Anti TPO is measured by ELISA and the effect of vitamin D level on the level of Anti TPO in the serum is examined.
Secondary outcomes
1
Description
Evaluation of serum vitamin D levels in patients with Anti TPO positive
Timepoint
Serum vitamin D levels are measured before the intervention and 3 and 6 months after the start of vitamin D intake
Method of measurement
After starting the study, blood samples are taken from the patients and the patients' serum is removed. Using special Vitamin D kits, the level of vitamin D is measured by ELISA.
Intervention groups
1
Description
Intervention group: Patients who are Anti-TPO positive and have elevated TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng /ml . For 8 weeks, 50,000 units of vitamin D3 tablets will be prescribed every week. After 8 weeks, 800 to 1000 units of vitamin D will be prescribed daily.
Category
Treatment - Drugs
2
Description
Intervention group: Patients who are anti-TPO positive and have elevated TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml. 800 to 1000 units of vitamin D are prescribed daily for 3 months.
Category
Treatment - Drugs
3
Description
Intervention group: Patients who are anti-TPO positive and have normal TSH and are deficient in vitamin D whose serum level of vitamin D is less than 10ng/ml. For 8 weeks, 50,000 units of vitamin D3 tablets will be prescribed every week. After 8 weeks, 800 to 1000 units of vitamin D will be prescribed daily.
Category
Treatment - Drugs
4
Description
Intervention group: Patients who are anti-TPO positive and have normal TSH and insufficient vitamin D with serum levels of vitamin D between 10ng/ml to 20ng/ml. 800 to 1000 units of vitamin D are prescribed daily for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadr Laboratory
Full name of responsible person
Sima shahmohammdi Farid
Street address
Tabriz, Vala Asr uphill
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
shahmohammadis@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 5333 0896
Email
reasearch-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sima Shahmohammadi Farid
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
shahmohammadis@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Shahmohammadi Farid
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
shahmohammadis@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Yousefipour
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No1026,East Second floor, Azarabadegan Ave, Third daneshgah Ave, Nasr Town
City
Tabriz
Province
East Azarbaijan
Postal code
5158375751
Phone
+98 41 3662 8155
Email
ali_you_2015@yahoo.co.uk
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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data will be shared.
When the data will become available and for how long
2023-2024
To whom data/document is available
Researchers and academic staffs
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
Request via email:ali_you_2015@yahoo.co.uk
What processes are involved for a request to access data/document