Protocol summary

Study aim
Determination of the effects of synbiotic supplementation on anthropometric indices, Inflammatory and hormone profiles in hypothyroid patients
Design
This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. Fifty six participants will randomly allocated to receive synbiotic per day (n = 28) or placebo (n = 28).
Settings and conduct
In this study, people with hypothyroidism who are being treated with standard dose levothyroxine will recruited from Isfahan Endocrine & Metabolism Research Center (IEMRC) and Al-Zahra clinic , Isfahan, Iran. Subjects will stratified according to gender. Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist.The synbiotic supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1) Age of 18 to 65 years; 2) Hypothyroid patients with a history of treatment for more than one year using levothyroxine sodium; 3) TSH is at least one year with a constant dose of levothyroxine in the normal range; 4) No smoking and alcohol; 5) Non pregnant, non-lactating; 6) Willingness to participation in the study Exclusion criteria: 1) Thyroid cancer; 2) Intestinal malabsorption (history of obstructive surgery, inflammatory bowel disease, celiac disease); 3) Antibiotic use; 4) Acute and chronic infectious diseases
Intervention groups
Individuals will randomly divided into two groups to receive 500 mg familact synbiotic supplementation or placebo per day for 8 weeks.
Main outcome variables
Weight;Waist circumference;BMI;WHR;Systolic blood pressure;Diastolic blood pressure;C-reactive protein;Thyroid-stimulating hormone;FreeT3;Anti-thyroid peroxidase

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N35
Registration date: 2018-10-28, 1397/08/06
Registration timing: prospective

Last update: 2018-10-28, 1397/08/06
Update count: 0
Registration date
2018-10-28, 1397/08/06
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic supplementation on anthropometric indices, Inflammatory and hormone profiles in patients with hypothyroidism
Public title
synbiotic and hypothyroidism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years Hypothyroid patients with a history of treatment for more than one year using levothyroxine (sodium) TSH is at least one year with a constant dose of levothyroxine in the normal range No smoking and alcohol Non pregnant, non-lactating Non-use of drugs that affect metabolism and absorption of levothyroxine include: iron sulfate, magnesium sulfate, warfarin, luvastatin, amiodarone, sumatropin, calcium carbonate, orlistat, multivitamin and minerals, theophylline, ritunavir, rifampin, phenytoin, karmazapine, Phenobarbital, Sucralfate, Aluminum hydroxide, Sertraline, Bile doses, Estrogens and other estrogen modifying drugs, Proton pump suppressants, Phosphate binders People who, after explaining the work, were willing to cooperate and answer questions and conduct experiments
Exclusion criteria:
Thyroid cancer Intestinal malabsorption (history of obstructive surgery, inflammatory bowel disease, celiac disease) Antibiotic use Acute and chronic infectious diseases Use of drugs that affect the absorption and metabolism of levothyroxine, including (iron sulfate, magnesium sulfate, warfarin, luvastatin, amiodarone, sumatropin, calcium carbonate, orlistat, multivitaminomineral, theophylline, ritunavir, rifampin, Tween, Karmazpine, Phenobarbital, Sucralfate, Aluminum Hydroxide, Sertraline, Bile Drug, Estrogen and other estrogen modifying drugs, proton pump inhibitor drugs, phosphate binders)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two synbiotic and placebo groups.The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial (participant, researcher). The familact synbiotic supplement and its placebo will be produce by Zist takhmir company . Synbiotic supplement and its placebos will in the same form of package and the patients and researcher will not aware of the content of the pack until the end of trial.
Placebo
Used
Assignment
Parallel
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
Hezarjarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-10-19, 1397/07/27
Ethics committee reference number
IR.MUI.MED.REC.1397.102

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
Thyroid-stimulating hormone
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA)

2

Description
Free triiodothyronine (FT3)
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA)

Secondary outcomes

1

Description
Anti-thyroid peroxidase
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA)

2

Description
C-reactive protein
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Laboratory analysis

3

Description
Weight
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Digital scale

4

Description
Waist Circumference
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
non-stretching tape measure

5

Description
Waist / hip ratio - WHR
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
non-stretching tape measure

6

Description
Systolic blood pressure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Sphygmomonometer

7

Description
Diastolic blood pressure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Sphygmomonometer

8

Description
Body Mass Index
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Dividing the weight into kilograms by squared height by meter

9

Description
Depression score
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Depression Anxiety and Stress Scales (DASS-21)

10

Description
Anxiety score
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Depression Anxiety and Stress Scales (DASS-21)

11

Description
Stress score
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Depression Anxiety and Stress Scales (DASS-21)

12

Description
Appetite
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Visual Analogue Scale

13

Description
Multidimensional Fatigue Inventory
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
multidimensional fatigue inventory (MFI-20)

14

Description
Fatigue Intensity
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Fatigue severity scale (FSS)

15

Description
Quality of Life
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
World Health Organization Quality of Life Questionnaire 26 questions (WHOQOL-BREF)

16

Description
Constipation , bowel habits, abdominal symptoms
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Constipation , bowel habits, abdominal symptoms questionnaire

17

Description
Body fat percentage
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Bioimpedance

Intervention groups

1

Description
Intervention group: A daily dose of 500 mg of FimiLact synbiotic capsule was read 2 hours after Levothyroxine tablet for 8 weeks (dosage of 1 capsule per day). Synthetic FamiLact Synthetic Foam Supplement will be manufactured by Iranian Zist Takhmir Company.
Category
Treatment - Other

2

Description
Control group: Each day, 1 placebo (starch 375 mg, lactose 22 mg, magnesium stearate 1 mg, 1 mg silicon dioxide, 1 mg talc) will receive 2 hours after levothyroxine for 8 weeks.The placebo will be made by Tehran Zist Takhmir Company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine & Metabolism Research Center
Full name of responsible person
Gholamreza Askari
Street address
Korram Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Fax
+98 31 3668 1378
Email
Askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib Ave, Isfahan University of Medical Sciences
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@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
Gholamreza Askari
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave.
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Email
askari@mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Askari
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib streetو Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Askari
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib streetو Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir

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
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
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
Title and more details about the data/document
The collected deidentified for the primary outcome measure only will be shared.
When the data will become available and for how long
starting 12 months after publication.
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
The data will provide for educational use.
From where data/document is obtainable
Dr. Gholamreza Askari askari@mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.
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