Determination of the effect of selenium supplementation on serum T4 levels in children with subclinical hypothyroidism
Determining the effect of selenium supplementation on serum TSH levels in children with subclinical hypothyroidism
Design
Clinical trial with control group with parallel, double-blind, randomized, phase 3 groups on 148 patients, Excel software rand function was used for randomization.
Settings and conduct
The study will be performed in Gorgan Endocrinology Clinic and Taleghani Pediatric Hospital based on subclinical hypothyroidism in children by examination. Patients will be randomly divided into two intervention and control groups and do not know the type of intervention received. Finally, after 3 months of receiving the drug, the two groups are evaluated by a specialist without knowing the type of patient group.
Participants/Inclusion and exclusion criteria
Children 3-16 years old
Satisfaction to participate in the study
With subclinical hypothyroidism (high TSH level and normal FT4 level and no medication)
Intervention groups
Children with subclinical hypothyroidism will be randomly assigned to one of two intervention or control groups.
The intervention group will take one selenium supplement tablet containing 200 micrograms of selenium daily for 3 months. The control group will give the same placebo.
Main outcome variables
Evaluation of patient recovery using selenium supplementation based on TSH and T4 results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220314054284N1
Registration date:2022-06-22, 1401/04/01
Registration timing:registered_while_recruiting
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
bahareh hooshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3232 0661
Email address
bahareh_hooshyar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Selenium Supplement on subclinical Hypothyroidism in children
Public title
The Effect of Selenium Supplement on subclinical Hypothyroidism in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with subclinical hypothyroidism
Age 3- 16 years
Exclusion criteria:
Dissatisfaction with participating in the study
Failure to follow the patient
Lack of patient medication compliance by parents
Age
From 3 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to experimental and control groups using the random block method. To perform randomization using quadruple blocks, first by throwing 16 regular hexagons 16 times, a random sequence of 16 quadruple blocks will be generated from the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA In the sequence, there will be 32 of each letter A and B. According to the above block, 64 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 64. The person delivering the envelopes to the patients does not know the letters inside. Randomization is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each envelope. Patients who received the letter A will be in the intervention group and patients who received the letter B will be in the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
After randomly assigning the patients, the patient group and the control group will use the same drug (with the same packaging). After 3 months of receiving the drug, the patients will be evaluated by an endocrinologist who is not aware of the allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of golestan University of Medical Sciences
Street address
at the beginning of Shast Kola Road,Hyrkan Boulevard,Basij Square
City
gorgan
Province
Golestan
Postal code
4934174515
Approval date
2022-03-17, 1400/12/26
Ethics committee reference number
IR.GOUMS.REC.1401.001
Health conditions studied
1
Description of health condition studied
Subclinical hypothyroidism
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism
Primary outcomes
1
Description
The amount of changes in the level of primary variables (TSH)
Timepoint
Sections for measuring thyroid hormone levels (TSH) before the intervention and 3 months after (as soon as the treatment period ends)
Method of measurement
Comparison of the effect of selenium supplementation on the reduction of TSH level
2
Description
The amount of changes in the level of primary variables (selenium)
Timepoint
Sections for measuring of selenium level before the intervention and 3 months after (as soon as the treatment period ends)
Method of measurement
Comparison of the effect of selenium supplementation on selenium changes
3
Description
The amount of changes in the level of primary variables of FT4
Timepoint
Sections for measuring of FT4 level before the intervention and 3 months after (as soon as the treatment period ends)
Method of measurement
Comparison of the effect of selenium supplementation on the reduction of T FT4 level
Secondary outcomes
1
Description
Changes in the body's metabolism
Timepoint
Before and 3 months after the start of the intervention
Method of measurement
Evaluation of weight, improvement of patient symptoms including constipation, fatigue, appetite, brittle nails and hair loss, etc.
Intervention groups
1
Description
Intervention group: Intervention group: In patients with subclinical hypothyroidism, levothyroxine treatment will be started after 3 to 6 months of follow-up. The treatment will be based on age and sex. Iran will be consumed once a day.
Category
Treatment - Drugs
2
Description
Control group: The main treatment (levothyroxine) for each placebo drug similar to the desired supplement containing starch will take one daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital and Gorgan Private Endocrinology Clinic
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
Undecided - It is not yet known if there will be 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
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Dr. Hossein Zairi, Pediatric Endocrinologist
Mobile number: 09113554671
Office phone number: 01732320661
Office address: Gorgan, Valiasr St., 22 Adalat, Sarv Building, third floor
Email: dr.zaeri_endocrine @ YAHOO.COM
What processes are involved for a request to access data/document
The applicant should provide his / her study file and the purpose of receiving the data in the form of an email with his / her research file (research plan), then after 3 months the file will be provided to the person.