The effects of hot-tempered diet on signs, symptoms and serum thyroid hormones level in Symptomatic but euthyroid hypothyroid patients treated with levothyroxine.
Determining the effect of hot-tempered diet, based on traditional medicine reference texts, on the signs and symptoms and level of thyroid hormones in patients with symptomatic euthyroid hypothyroidism treated with levothyroxine.
Design
The treatment group with a sample size of 49 people will be selected from among the patients referred to the internal clinic.People will be given a warm diet based on traditional medicine and will be blinded about the type of diet they receive.Patients' nutritional status is checked at the beginning and every three days in the form of food frequency.The Zolowski clinical questionnaire is completed at the first visit and the necessary tests are performed on the first day of the visit.Patients are required to follow a diet for 6 weeks,After that, they will be re-visited and completed the Zolowski questionnaire and re-tested.
Settings and conduct
After informed consent has been accepted, eligible patients are examined and Zulewski score will be determine,also serum levels of TSH, total T3, ALT and creatinin will be also measured. Then, specific diet will be taught to individual.After six weeks the patient will be re-visited and the initial questionnaire will completed again and the serum levels of TSH, total T3 and ALT and creatinin will be checked again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hypothyroid patients, aged 18 to 65 y/o who have been treated with levothyroxine whit normal TSH in the last 3 months and have a Zulewski score>3 on examination.
Exclusion criteria: pregnancy; chronic diseases; change in drug dose during the study, Non-compliance with the diet, at least 70% based on the form of food frequency.
Intervention groups
The intervention is change diet to hot-tempered for 6 weeks. This diet change, will be after educating to patients.
Main outcome variables
Zulewski score; serum level of TSH; T3; ALT and creatinine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220608055102N1
Registration date:2022-06-13, 1401/03/23
Registration timing:prospective
Last update:2022-06-13, 1401/03/23
Update count:0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Ali Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3324 4052
Email address
ali.azizi.bh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-01, 1401/04/10
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of hot-tempered diet on signs, symptoms and serum thyroid hormones level in Symptomatic but euthyroid hypothyroid patients treated with levothyroxine.
Public title
The effect of hot-tempered diet on the signs and symptoms and levels of thyroid hormones
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hypothyroid patients have been treated with levothyroxine.
Patients who have had normal TSH(5-5/0) in the last 3 months.
Zulewski score Zulewski score > 3.
Exclusion criteria:
Pregnancy.
Hypothyroidism caused by surgery or radioactive iodine.
Chronic diseases such as diabetes mellitus.
Dose changing of levothyroxine during the study.
Taking interfering drugs with thyroid tests.
Diseases of the hypothalamus and pituitary gland.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
49
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, all patients before and after receiving the diet were examined for the Zulewski score and serum levels of TSH and Total T3 were measured; Since the scoring is filled out by the clinic doctor, the examinator is unaware of the study and the reason behind the examination.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan, Hezar Jerib St., Isfahan University of Medical Sciences, Building No. 3, School of Medicine, Ground Floor, Department of Medical Ethics
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.MUI.MED.REC.1399.764
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03.9
ICD-10 code description
Hypothyroidism, unspecified
Primary outcomes
1
Description
Zulewski score
Timepoint
At the beginning and 6 weeks later
Method of measurement
Zulewski questionnaire
2
Description
Thyroid stimulating hormone serum level
Timepoint
At the beginning and 6 weeks later
Method of measurement
Laboratory
3
Description
Triiodothyronine serum level
Timepoint
At the beginning and 6 weeks later
Method of measurement
Laboratory
4
Description
Alanine transaminase serum level
Timepoint
At the beginning and 6 weeks later
Method of measurement
Laboratory
5
Description
Creatinine serum level
Timepoint
At the beginning and 6 weeks later
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Each person is given dietary measures based on traditional Iranian medicine, which are classified as hot and cold temperament. These recommendations include eliminating cold-tempered foods and consuming hot-tempered foods. Patients are asked to complete the food frequency form twice a week, which will be reviewed at the next visit. Any patient who follows less than 70% of the recommendations Has been removed from the study.Educating each patient during the first visit is to explain the reason and method of study, a list of hot and cold foods, giving a sufficient number of food frequency forms and the contact number of the support doctor for emergencies.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Mohammad Shirzadi
Street address
Ebn-e-Sina St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
5314181486
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Web page address
http://amin.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Hezar Jarib Ave.
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
vcr-office@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
Mohammad Shirzadi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Alzahra hospital, Shohada e Soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
81746
Phone
+98 31 3620 1274
Email
omid.shirzadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Shirzadi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Alzahra hospital, Shohada e Soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
81746
Phone
+98 31 3620 1274
Email
omid.shirzadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Shirzadi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Alzahra hospital, Shohada e Soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
81746
Phone
+98 31 3620 1274
Email
omid.shirzadi@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary.
When the data will become available and for how long
Starting 6 months after publication.
To whom data/document is available
The data will be available for physicians working in academic institutions and also clinicians working in the field of internal medicine.
Under which criteria data/document could be used
The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of internal medicine.
From where data/document is obtainable
Applicants can contact Dr. Mohammad Shirzadi by email. Email address: omid.shirzadi@gmail.com
What processes are involved for a request to access data/document
Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.