Determining the effect of vitamin B1 on thyroid hormones and lipid profile of patients with hypothyroidism before and after intervention
Design
This before-and-after semi-experimental study will be conducted on 49 patients with hypothyroidism between the ages of 30 and 50 years with TSH values greater than 10 µIU/mL, T4 less than 4 ng/dL, and serum Anti-TPO levels greater than 200 U/mL with a diagnosis of hypothyroidism.
Settings and conduct
Endocrinology Clinic of Dezful's Ganjaviyan Hospital in the spring and summer of 1404
Participants/Inclusion and exclusion criteria
Patients with hypothyroidism between the ages of 30 and 50 years with TSH values greater than 10 µIU/mL, T4 less than 4 ng/dL, and serum Anti-TPO levels greater than 200 U/mL will be enrolled in the study with a diagnosis of hypothyroidism.
Intervention groups
Patients will receive the usual treatment for hypothyroidism (levothyroxine) and in addition to levothyroxine, they will also receive a 300 mg vitamin B1 tablet daily in the morning before breakfast and half an hour to 1 hour before taking levothyroxine.
Investigating the effect of vitamin B1 on thyroid hormones and lipid profile of patients with hypothyroidism receiving levothyroxine
Public title
The effect of vitamin B1 on patients with hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hypothyroidism
The ages between 30 and 50 years old
TSH levels greater than 10 µIU/mL
T4 levels less than 4 ng/dL
Serum Anti-TPO levels greater than 200 U/mL
Exclusion criteria:
History of thyroid surgery
Thyroid malignancies
Hypothyroidism resulting from hyperthyroidism treatment
Other known autoimmune and rheumatic diseases
Renal failure and malabsorption
History of use of antithyroid drugs
History of use of cytotoxics
History of use of immunosuppressants
History of use of immunomodulators
History of use of glucocorticoids
History of use of amiodarone, lithium, interferon, radioiodine,
History of chemotherapy
History of use of supplements containing vitamin B1
pregnancy
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
49
More than 1 sample in each individual
Number of samples in each individual:
2
Two blood samplings are performed at the beginning and end of the study to check hormonal and lipid variables.
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
Research Ethics Committees of Dezful University of Medical Sciences
Street address
Dezful, end of Azadegan Boulevard, next to the Traffic Department
City
Dezful
Province
Khouzestan
Postal code
6461653476
Approval date
2025-05-13, 1404/02/23
Ethics committee reference number
IR.DUMS.REC.1404.004
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism
Primary outcomes
1
Description
Thyroxine hormone (T4)
Timepoint
Before the start of the study and 1 month and 2 months after starting to take vitamin B1 tablets
Method of measurement
Blood collection from the patient and serum separation
2
Description
Thyroid-stimulating hormone (TSH)
Timepoint
Before the start of the study and 1 month and 2 months after starting to take vitamin B1 tablets
Method of measurement
Blood collection from the patient and serum separation
3
Description
serum Anti-TPO
Timepoint
Before the start of the study and 1 month and 2 months after starting to take vitamin B1 tablets
Method of measurement
Blood collection from the patient and serum separation
Secondary outcomes
1
Description
Serum total cholesterol (TC)
Timepoint
Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets
Method of measurement
Blood collection and serum separation from the patient
2
Description
Serum LDL-C
Timepoint
Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets
Method of measurement
Blood collection and serum separation from the patient
3
Description
Serum HDL-C
Timepoint
Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets
Method of measurement
Blood collection and serum separation from the patient
4
Description
LDL-C to HDL-C ratio
Timepoint
Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets
Method of measurement
Blood collection and serum separation from the patient
5
Description
Serum triglycerides (TG)
Timepoint
Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets
Method of measurement
Blood collection and serum separation from the patient
6
Description
Serum VLDL
Timepoint
Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets
Method of measurement
Blood collection and serum separation from the patient
7
Description
Atherogenic index
Timepoint
Before the start of the study and 1 and 2 months after receiving vitamin B1 tablets
Method of measurement
Blood collection and serum separation from the patient
Intervention groups
1
Description
In the present before-and-after semi-experimental study, 49 patients with hypothyroidism between the ages of 30 and 50 years with TSH levels greater than 10 µIU/mL and T4 less than 4 ng/dL and serum Anti-TPO levels greater than 200 U/mL will be enrolled in the study with a diagnosis of hypothyroidism. Patients will receive the usual treatment for hypothyroidism, namely levothyroxine, and in the intervention group, in addition to levothyroxine, they will receive 300 mg of vitamin B1 tablet daily in the morning on an empty stomach and half to 1 hour before taking levothyroxine. The duration of the treatment period is 2 months. After the end of 2 months of treatment, blood samples will be taken from the patients and the variables of TSH, T4, Anti-TPO, TG, TC, LDL-C, HDL-C, and VLDL in the patients' serum will be measured. On the other hand, the LDL-C/HDL-C ratio and the atherogenic index will be calculated based on the formula (TG/HDL-C) log.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic, Ganjovian Hospital, Dezful
Full name of responsible person
Vali Moradi
Street address
At the beginning of the Dezful-Andimeshk road, opposite the 292nd Armored Brigade
City
Dezful
Province
Khouzestan
Postal code
6461653476
Phone
+98 61 4242 9533
Email
aliakbar_oroojan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Behmanesh
Street address
Dezful, end of Azadegan Boulevard, next to the Traffic Department
City
Dezful
Province
Khouzestan
Postal code
6461653476
Phone
+98 61 4242 9533
Email
aliakbar_oroojan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezfoul 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
Dezfoul University of Medical Sciences
Full name of responsible person
Ali Akbar Oroojan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dezful, end of Azadegan Boulevard, next to the Traffic Department, New Medical School, Faculty of Education Vice Chancellor's Office
City
Dezful
Province
Khouzestan
Postal code
6461653476
Phone
+98 61 4242 9533
Fax
Email
aliakbar_oroojan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Ali Akbar Oroojan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dezful, end of Azadegan Boulevard, next to the Traffic Department, New Medical School, Faculty of Education Vice Chancellor's Office
City
Dezful
Province
Khouzestan
Postal code
6461653476
Phone
+98 61 4242 9533
Fax
Email
aliakbar_oroojan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Ali Akbar Oroojan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Dezful, end of Azadegan Boulevard, next to the Traffic Department, New Medical School, Faculty of Education Vice Chancellor's Office
City
Dezful
Province
Khouzestan
Postal code
6461653476
Phone
+98 61 4242 9533
Fax
Email
aliakbar_oroojan@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
In accordance with the principles of publishing and writing articles for this category of studies, the results of this study can be published as an average in the resulting article and will not be published individually.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some data, such as information related to the main outcome and the results of laboratory analyses performed, can be shared.
When the data will become available and for how long
After the article is published
To whom data/document is available
The data results will be published in the paper from the current study and will be visible to all researchers.
Under which criteria data/document could be used
Documentation for the implementation and conduct of future studies by researchers is available in the form of a printed article, which will also be made available to the Vice President for Education, Research, and Technology of the university.
From where data/document is obtainable
Vice President for Education, Research and Technology
Contact Number: 00986142429533
Zip Code: 6461653476
What processes are involved for a request to access data/document
A formal letter of request should be sent to the Vice Chancellor for Education, Research and Technology of Dezful University of Medical Sciences and they will receive their official response. This process takes approximately 1 month.