The main purpose of this study is to evaluate endothelial dysfunction in hypothyroid neonates.In this study, ten infants with TSH = 10-50, ten infants with TSH=50-100 and ten infants with serum TSH above 100 are selected.
30 healthy neonates also are selected. From hypothyroid patients before treatment and 4 weeks after treatment with Levothyroxin (10 micrograms per Kg per day) indices of Endothelial Dysfunction is measured. Mean factor levels will be compared before and after therapy in hypothyroid neonates between healthy infants and hypothyroid neonates before treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812153493N1
Registration date:2010-05-25, 1389/03/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-25, 1389/03/04
Registrant information
Name
Mahin Hashemipour
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 5555
Email address
hashemipour@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Applied Physiology Research Center
Expected recruitment start date
2009-01-19, 1387/10/30
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of endothelial dysfunction in hypothyroid neonates that referred to Endocrine & Metabolic Research Center of Isfahan
Public title
Evaluation of endothelial dysfunction in hypothyroid neonates that referred to Endocrine & Metabolic Research Center of Isfahan
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 2 weeks,
Exclusion criteria: Presence of any proven disease, receiving any drug, Small for gestational age infants, presence of Septicemia, presence of inherited metabolic diseases
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Applied Physiology Research Center
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
empty
Ethics committee reference number
287225
Health conditions studied
1
Description of health condition studied
endothelial dysfunction in neonate with hypothyroidism
ICD-10 code
E03
ICD-10 code description
Primary outcomes
1
Description
Von-Willbrand factor
Timepoint
before and 4 weeks after treatment with Levothyroxin
Method of measurement
ELISA
2
Description
ICAM
Timepoint
before and 4 weeks after treatment with Levothyroxin
Method of measurement
ELISA
3
Description
VICAM
Timepoint
before and 4 weeks after treatment with Levothyroxin
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Levothyroxin 10 micrograms per kg per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine & Metabolic Research Center of Sediqheh Tahere Isfahan
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Applied Physiology Research Center
Full name of responsible person
Dr. Shaqhaieqh Haqhjoo
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?