Protocol summary

Study aim
Determining the effect of combined iron and vitamin C supplementation on thyroid hormone status, blood parameters, and quality of life in patients with hyperthyroidism
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients
Settings and conduct
In this study, people with hyperthyroidism, referred to Firoozgar Hospital, who were eligible to participate in the study based on inclusion and exclusion criteria, are asked to complete a written informed consent form. Individuals will be randomly assigned to one of two groups receiving the intervention and a placebo. Then, at the beginning and end of the study, 10 cc of blood will be taken from people and the levels of inflammatory factors, thyroid hormones and blood factors will be measured. Double blind study (Participants and researcher). Iron vitamin c and placebo tablets will be placed into identical containers and all investigators and participants will be blinded to the random assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women over 18 years of age with hyperthyroidism with body mass index 18.5 to 30 kg / m2, hemoglobin level less than 12.7 and 13 g / dL in men and women, start drug treatment Exclusion criteria: autoimmune diseases, chronic, infectious and other thyroid disorders, taking vitamin C iron supplement in the last month
Intervention groups
Intervention group: 40 men and women with hyperthyroidism receive two tablets of 27 mg of iron and 100 mg of vitamin C daily for 8 weeks each. Placebo group: 40 men and women with hyperthyroidism take two placebo tablets (containing maltodextrin) daily, which are similar in appearance to iron and vitamin C supplements, for 8 weeks each.
Main outcome variables
The primary Outcome in this study is TSH level.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090822002365N27
Registration date: 2022-03-04, 1400/12/13
Registration timing: registered_while_recruiting

Last update: 2022-03-04, 1400/12/13
Update count: 0
Registration date
2022-03-04, 1400/12/13
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of iron and vitamin C co-supplementation on thyroid hormones, hematological parameters, oxidative stress, inflammation, and quality of life in hyperthyroidism patients
Public title
Effect of iron and vitamin C co-supplementation in hyperthyroidism patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women over 18 years of age with newly diagnosed hyperthyroidism Body mass index18.5-30 kg / m2 Hemoglobin level less than 12.7 g / dl for women and less than 13 g / dl for men Start a medication program No autoimmune diseases and chronic diseases such as diabetes, hypertension, kidney, liver, gallbladder, thyroid, parathyroid, bone, gastrointestinal and hyperphosphatemia disorders No infectious diseases, malignancies and severe bleeding in the last 2 months No thalassemia and other blood disorders Do not use hormonal drugs, anticonvulsants, cholesterol and fat lowering drugs, antacids, blood thinners, and laxatives. Do not take iron and vitamin C supplements during the last month No history of other thyroid disorders In the case of women, the absence of abnormal and irregular menstrual cycles No pregnancy and lactation Willingness to cooperate
Exclusion criteria:
Having any acute illness Changes in medications Non-regular use of supplements and acceptance rate less than 90% Migration Exclusion based on personal preference of participants
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
For randomized allocation performing, permuted block randomization will be used by blocks with size of 4. According to the sample size of 80subjects, 20 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to performing the double-blinded of study, before study beginning, the canisters containing tablets can be provided by someone other than the researcher, and the placebo tablets in appearance are similar to the supplementation tablets and the researcher are not be aware about the allocation of studied subjects in each group during the evaluation of the studied outcomes until the end of the intervention period.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Hemmat Express way, Iran University of Medical Science
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.IUMS.FMD.REC.1400.601

Health conditions studied

1

Description of health condition studied
Hyperthyroidism
ICD-10 code
E05
ICD-10 code description
Thyrotoxicosis [hyperthyroidism]

2

Description of health condition studied
Iron deficiency anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anemia

Primary outcomes

1

Description
thyroid stimulating hormone
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
The level of TSH in serum is with ELISA method

Secondary outcomes

1

Description
High-sensitive C-reactive protein (hs-CRP)
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
The level of Hs-CRP in serum is with ELISA method

2

Description
Free thyroxine hormone levels
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
The level of FT4 in serum with ELISA method

3

Description
free triiodothyronine Hormone Levels
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
The level of FT3 in serum with ELISA method

4

Description
Malondialdehyde
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
The level of MDA in serum with ELISA method

5

Description
Total antioxidant capacity
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
The level of TAC in serum with ELISA method

6

Description
Hemoglobin
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
Using an automated Hematology analyzer

7

Description
Red blood cell
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
Using an automated Hematology analyzer

8

Description
mean corpuscular volume
Timepoint
At the baseline and after 8 weeks of intervention
Method of measurement
Using an automated Hematology analyzer

Intervention groups

1

Description
Intervention group: 40 men and women with hyperthyroidism receive two tablets of 27 mg of iron supplement and 100 mg of vitamin C daily for 8 weeks each.
Category
Treatment - Other

2

Description
Control group: 40 men and women with hyperthyroidism, each receiving 8 placebo tablets (containing maltodextrin) daily for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Fatemeh golgiri
Street address
Tehran, Valiasr Square, Karim Khan Zand St., Beh Afarin St.
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1201
Fax
+98 21 8894 2622
Email
h_firoozgar@yahoo.com
Web page address
https://firoozgar.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Street address
Department of nutrition, School of Health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4743
Fax
+98 21 8862 2707
Email
vafa.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, School of health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4743
Email
vafa.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad reza vafa
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, School of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4743
Email
vafa.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4743
Email
vafa.m@iums.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
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
A part of the data will be shared, such as primary outcomes
When the data will become available and for how long
Four months after the publication of the results
To whom data/document is available
Researchers and students of university
Under which criteria data/document could be used
Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis.
From where data/document is obtainable
Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Department of nutrition, school of health, Iran university of medical sciences, Hemmat highway, Tehran. Phone number: 0098 21 86704743. E-mail: vafa.m@iums.ac.ir
What processes are involved for a request to access data/document
Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Department of nutrition, school of health, Iran university of medical sciences, Hemmat highway, Tehran. Phone number: 0098 21 86704743. E-mail: vafa.m@iums.ac.ir
Comments
Loading...