This study is a clinical trial to determine the effect of vitamin C supplementation on thyroid function in patients with primary hypothyroidism of both sexes between 18-75 years old, under treatment of oral levothyroxine. Patients with TSH levels between 0.5 to 4.5 micrograms per liter and take certain levothyroxine dose for at least 6 months of the study without any changes will study but patients with thyroid cancer, pregnant or nursing, taking OCP or estrogen and testosterone during 3 months ago and chronic gastrointestinal diseases will be excluded. Patient will treat with certain brand of levothyroxine sodium. At first Levels of fasting TSH, T4, T3 will be measured and recorded. Patients will treat with levothyroxine for 8 weeks and then the level of TSH, T4, T3 will be measured and recorded. Then the patients will treat with levothyroxine plus 500 mg vitamin C daily, at morning when pateints are fast, with 200 cc of water. After 8 weeks, thyroid function will be checked. All tests will be done in certain labratory. Results in patients before and after the end of treatment will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102124634N1
Registration date:2016-05-31, 1395/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-31, 1395/03/11
Registrant information
Name
Hamid Kazemzad
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86334172517
Email address
h.kazemzad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department Arak University of Medical Sciences
Expected recruitment start date
2015-03-16, 1393/12/25
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin C supplementation on thyroid function in patients with primary hypothyroidism
Public title
The effect of vitamin C on thyroid function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: TSH level between 0.5 and 4.5 micrograms per liter; taking levothyroxine dose for at least 6 months without changes.
Exclusion criteria: thyroid cancer; pregnant or nursing; taking OCP or estrogen and testosterone during 3 months ago; chronic GI disease.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
73
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Alamolhoda, Maskan, Arak
City
Arak
Postal code
Approval date
2014-10-17, 1393/07/25
Ethics committee reference number
93-176-3
Health conditions studied
1
Description of health condition studied
Primary hypothyroidism
ICD-10 code
E03.8, E03
ICD-10 code description
Other specified hypothyroidism, Hypothyroidism, unspecified
Primary outcomes
1
Description
T3, T4
Timepoint
Arrival, 8 weeks after treatment
Method of measurement
In ng / dl using a blood test
Secondary outcomes
1
Description
TSH
Timepoint
Arrival, 8 weeks after treatment
Method of measurement
In U/ml using a blood test
Intervention groups
1
Description
8 weeks treatment with levothyroxine dose control with the Company, iran hormone and 8 weeks treatment with levothyroxine plus 500 milligrams of vitamin C daily morning fasting in the 200 cc model manufactured by water
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak AmirAlmomenin Hospital
Full name of responsible person
Dr. Kazemzad Hamid
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
School of Medicine, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical sceinces
Full name of responsible person
Dr. Kazemzad Hamid
Position
Assistant Internal Medicine
Other areas of specialty/work
Street address
AmirAlmomenin Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3312 4922
Fax
Email
h.kazemzad@arakmu.ac.ir; rahenorayaneh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Kazemzad Hamid
Position
Assistant Internal Medicine
Other areas of specialty/work
Street address
AmirAlmomenin Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3312 4922
Fax
Email
h.kazemzad@arakmu.ac.ir; rahenorayaneh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hamid Kazemzad
Position
Assistant internal medicine
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3417 3517
Fax
Email
rahenorayaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)