Evaluation the effectiveness of administering levothyroxine in morning versus evening on thyroid factor number 4 and thyroid stimulating hormon in sari hypothyroid patients
In this study, administering of levothyroxine sodium for hypothyroid patients in morning versus evening is evaluating.
The main objective of this study is to determine consuming the levothyroxine in the morning has better effect or in the evening?
During the study 50 patients that come to the Endocrinology clinic in sari city of Iran for treatment of hypothyroidism will enter to the study and each patient will get 2 pills every day. One pill is levothyroxine and the other is placebo.
Placebo contains levothyroxine exipians with no effective substance. The drug‘s dose that each patient intake is administering by doctor.
This study is crossover. 2 group with 25 people are chosen accidently.
The first group takes levothyroxine in the morning and placebo in the evening and the second one takes levothyroxine in the evening and placebo in the morning; After 2 month tow group will exchange together.
Before starting the treatment, at the end of the first 2 month and at the end of 4 month, thyroid factors will be checked.
Finally results will be compared and analyzed statistically in each group and between groups.
During the study a request form including all of the patient's identification is filled.
Primary end point contains obvious changing in thyroid factor number 4 and thyroid stimulating factor.
Secondary end point contains removing the primary complaint, changing in weight, blood pressure and efficacy of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903223014N2
Registration date:2011-04-10, 1390/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-10, 1390/01/21
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of administering levothyroxine in morning versus evening on thyroid factor number 4 and thyroid stimulating hormon in sari hypothyroid patients
Public title
Evaluation of administering levothyroxine in morning versus evening in Sari hypothyroid patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
patients with hypothyroidism, up to 18
Exclusion:
pregnant, GI problems, drugs which interact with levothyroxine
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics department of Mazandaran University of Medical Sciences
Street address
Ethics department of Mazandaran University of Medical Sciences, Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, sari, Mazandaran, Iran
City
Sari
Postal code
Approval date
2010-01-25, 1388/11/05
Ethics committee reference number
200
Health conditions studied
1
Description of health condition studied
hypothyroidism
ICD-10 code
E00-E07
ICD-10 code description
thyroid gland disorders
Primary outcomes
1
Description
TSH
Timepoint
every 2 month
Method of measurement
with lab kit
2
Description
T4
Timepoint
every 2 months
Method of measurement
with lab kit
Secondary outcomes
1
Description
primary complaint
Timepoint
every 2 months
Method of measurement
request form
2
Description
changing in weight
Timepoint
Every 2 month
Method of measurement
recuest form
3
Description
Efficacy of life
Timepoint
Every 2 month
Method of measurement
Recuest form
Intervention groups
1
Description
During the study 50 patients who are going to the endocrinology clinic of Sari for treating their hypothyroidism enter to the study.
These people divided in two 25people group.
During the first 2 month the first group takes levothyroxine 30 minute before breakfast. Intake dose for each person is determined by doctor.
Then during the second two month patients take levothyroxine 30 minute before dinner in the evening.
For the second group taking levothyroxine during the first and second 2 month will cross over.
Category
Treatment - Drugs
2
Description
During the study 50 patients who are going to the endocrinology clinic of Sari for treating their hypothyroidism enter to the study.
These people divided in two 25people group.
Each group should take placebo one time a day.
Placebo contains all of the levothyroxine exipians without effective substance.
During the first 2 month the first group takes placebo in the evening, 30 minute before dinner. Intake dose for each person is similar to levothyroxine that is consumed per day.
Then during the second two month patients take placebo in the morning, 30 minute before breakfast.
For the second group taking levothyroxine during the first and second 2 month will cross over.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
tooba special clinic
Full name of responsible person
Neda Sasanpour
Street address
Tooba special clinic, Khazar street, Sari, Iran
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Vice chancellor for research of Mazandaran univercity pharmacy colledge, Dr Shahram ala
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences, Vice chancellor for research
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
Mazandaran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Neda Sasanpour
Position
Pharmacy student
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 31 1234 6378
Fax
Email
sasanpoorneda@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr shahram Ala
Position
Clinical pharmacy specialist, Associated professor
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
+98 15 1354 3084
Email
sh204ala@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)