Effect of vitamin D supplementation on metabolic status, thyroid hormones, serum irisin and obesity indices in women with subclinical hypothyroidism
Design
A randomized, double-blind, placebo-controlled trial
Settings and conduct
44 patients with subclinical hypothyroidism will be randomly divided into two groups: the group receiving vitamin D (one perl 50,000 units per week) and the group receiving placebo (one perl containing sunflower oil similar to vitamin D). The patients will be selected from the endocrinology clinic of Imam Reza Hospital in Tabriz.
Participants/Inclusion and exclusion criteria
A total of 44 patients with hypothyroidism will be selected based on the inclusion criteria and informed written consent will be obtained from all participants before enrollment.
Inclusion criteria: willingness to participate in the study, women aged 20 to 65 years with hypothyroidism, BMI25-37 Kg / m2, laboratory TSH between 5-10 micro units per ml and normal T3 and T4, test Anti-TPO positive; Exclusion criteria: unwillingness to participate in the study; Serum vitamin D level higher than 100 micrograms per liter; Smoking and alcohol; Pregnancy and lactation; Diabetes and infectious heart disease; Renal failure; Cushing's syndrome; Liver disease; Use of drugs that affect the level of thyroid hormones including lithium, amiodarone, steroids, hypolipidemic drugs, antidepressants, oral contraceptives; Regular consumption of any dietary supplement during the last 2 months and during the study; Congenital hypothyroidism; Hypothyroidism due to radiation therapy to the head and neck
Intervention groups
1. Vitamin D supplement group (50000 units weekly) 2. Placebo group
Main outcome variables
glycemic indices; serum level of lipid profile; thyroid hormones; serum Irisin; anthropometric measurements; vitamin D serum
General information
Reason for update
Acronym
VITDHYPOT
IRCT registration information
IRCT registration number:IRCT20100408003664N25
Registration date:2021-10-23, 1400/08/01
Registration timing:prospective
Last update:2021-10-23, 1400/08/01
Update count:0
Registration date
2021-10-23, 1400/08/01
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on metabolic status, thyroid hormones, serum irisin and obesity indices in women with subclinical hypothyroidism
Public title
The effects of vitamin D supplementation in women with hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research
Women between the ages of 20 and 65 with subclinical hypothyroidism
BMI 25-37 Kg / m2
TSH 5-10 micro units per milliliter and freeT3 and free T4 are normal
Exclusion criteria:
Serum Vitamin D Levels higher than 100 μg / L
Smoking and alcohol
Pregnancy and lactation
Diabetes and infectious heart disease
Kidney failure
Cushing's syndrome
Liver diseases
Regular consumption of any dietary supplement during the last 2 months and during the study
Age
From 20 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants will be randomly allocated to intervention and placebo groups using a software-generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
In order to hide, a random sequence will not be provided to the executor and will be performed sequentially for each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo and supplement will be packed in the same number in similar packages. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study.
Placebo
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 Science
Street address
Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Approval date
2021-07-10, 1400/04/19
Ethics committee reference number
IR.TBZMED.REC.1400.327
Health conditions studied
1
Description of health condition studied
subclinical hypothyroidism
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism
Primary outcomes
1
Description
Serum Vitamin D
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
ELISA
2
Description
Glycemic indexes
Timepoint
Baseline and after 12 weeks after the intervention
Method of measurement
Glycemic indexes (from indicators of metabolic status) including fasting blood sugar by enzymatic method, insulin by ELISA and insulin resistance by formula, will be measured or calculated.
3
Description
lipid profile
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Lipid profile ( from indicators of metabolic status) including total cholesterol, triglycerides and high-density lipoprotein will be measured enzymatically, and low-density lipoprotein will be calculated using the friedwald formula.
4
Description
Thyroid hormones
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Thyroid hormones including thyroid stimulating hormone, triiodothyronine and thyroxine will be measured by ELISA.
5
Description
Irisin
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Obesity indices
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Obesity indices including weight with scales and waist circumference and hip circumference will be measured with a tape measure. Body mass index will be calculated with the formula.
2
Description
Body composition
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Body composition will be measured by Bio impedance (BIA) method usingTanita body composition analyzer.
3
Description
Dietary intake
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
The food record questionnaire will be used to assess food intake including energy, carbohydrate, protein and fat.
4
Description
Physical activity
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
The International Physical Activity Questionnaire will be used to measure physical activity.
Intervention groups
1
Description
Intervention group: 50000 units weekly vitamin D of Zahravi company for 3 month
Category
Treatment - Drugs
2
Description
Control group: Intake a Placebo perl containing sunflower oil, which is similar to vitamin D supplement in terms of dosage, color and size, once a week for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology clinic of Imam Reza Hospital , Tabriz
Full name of responsible person
Sara Safari
Street address
Imam Reza Hospital, Golghast Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
6717839391
Phone
+98 83 3724 7251
Email
sara.safari7@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Alireza Ostadrahimi
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabori avenue, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 3430
Email
nut-rc@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
Sara Safari
Position
MSc Student of Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabori Avenue , Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 83 3724 7251
Email
sara.safari7@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Raf raf
Position
Ph.D in Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabori Avenue , Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 83 3724 7251
Email
sara.safari7@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sara Safari
Position
دانشجوی کارشناسی ارشد علوم تغذیه
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
0098837247251
Email
sara.safari7@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available