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Effects of bed time vs morning levothroxine consumption on thyroid function in hypothyroid patients

Protocol summary

Summary
The aim of this quasi experimental study was timing effect of levothroxin on thyroid hormone.inclusion criteria was age above than 18; primary hypothyroidism and inclusion criteria was pregnancy; ocp consumption;this study was conducted with 100 patients with hypothyroidism referred to hospital's of Babol university of medical science .they divided in two groups(A and B). patients in group A were given levothyroxine in the morning half an hour before breakfast and in group B levothyroxine was given 2 hours after dinner(bedding time). All collected samples sent to same lab.Thyroid hormones were measured and compare in 2 groups before and 2 months after intervention. It was advised to all patients to used Iran Hormone made levothyroxine.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110235692N5
Registration date: 2013-05-22, 1392/03/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-22, 1392/03/01
Registrant information
Name
Mohammad ali Bayani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4651
Email address
m.bayani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Bobol University of Medical Siences and Health Services
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of bed time vs morning levothroxine consumption on thyroid function in hypothyroid patients
Public title
effect of levothroxine consumption time on thyroid hormone level
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:age>18; primary hypothyroidism exclusion criteria: pregnancy;ocp consumption; malabsorption disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Science
Street address
Babol Medical University, Ganj Afrooz St
City
Babol
Postal code
47745-47176
Approval date
2009-06-29, 1388/04/08
Ethics committee reference number
3762

Health conditions studied

1

Description of health condition studied
hypothyroidism
ICD-10 code
E00, E01,
ICD-10 code description
Disorders of thyroid gland

Primary outcomes

1

Description
TSH
Timepoint
before and 2 month after intervention
Method of measurement
lab test

Secondary outcomes

empty

Intervention groups

1

Description
levothroxine consumption in morning time
Category
Treatment - Drugs

2

Description
consumption of levothroxine in bed time
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohammad Ali Bayani
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bobol University of Medical Siences and Health Services
Full name of responsible person
Amro Allah MostafaZade
Street address
Ganj Afrooz St
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bobol University of Medical Siences and Health Services
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
Babol University of Medical Science
Full name of responsible person
Mohammad Ali Bayani
Position
endocrinologist
Other areas of specialty/work
Street address
Departman of internal medicine, Rohani Hospital, Ganj Afrooz St
City
Babol
Postal code
47745-47176
Phone
+98 11 1223 8301
Fax
Email
m.bayani@mubabol.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rohani hospital
Full name of responsible person
Mohammad Ali Bayani
Position
endocrinologist
Other areas of specialty/work
Street address
Departman of internal medicine, Rohani Hospital, Ganj Afrooz St
City
Babol
Postal code
47745-47176
Phone
+98 11 1223 8301
Fax
Email
m.bayani@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Mohhamad Ali Bayani
Position
Assistant of internal medicine
Other areas of specialty/work
Street address
Departman of internal medicine, Rohani Hospital, Ganj Afrooz St
City
Babol
Postal code
47745-47176
Phone
+98 11 1223 8301
Fax
Email
m.bayani@mubabol.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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