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The effect of cyproheptadin hydrochloride in treatment of mild to moderate failure to thrive in children who referred to clinics of Shiraz University of Medical Sciences at 1390

Protocol summary

Summary
Eighty patients with mild to moderate failure to thrive (according to Goomez criteria) and normal physical examination without any acute or chronic illness will be referred to laboratory for some paraclinical evaluations: CBC, BUN, venous blood gas, Na, K, Cr, U/A, Stool Exam, LFT, FBS, T4, TSH, TTG(IgA), Total IgA and bone scan. If all are normal, they will be enrolled in our study and their baseline weight (Wt) and height (Ht) will be recorded. Then they will be randomized to 2 equal groups to receive either combination of multivitamins and cyproheptadine (2mg of each/5cc ) or only multivitamins (2mg/5cc). The patients will consume these drugs as 0.25 mg/kg/day (divided to twice daily) for 4weeks then their Wt and Ht will be measured at the end of the treatment phase and 4 weeks later. Presumptive complications such as drowsiness or restlessness will be recorded in the clinic according to History and Physical Examination. Then results will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201268827N1
Registration date: 2012-02-22, 1390/12/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-02-22, 1390/12/03
Registrant information
Name
Khadijeh Sadat Najib
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4298
Email address
nzahrasan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-11-06, 1390/08/15
Expected recruitment end date
2012-03-17, 1390/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cyproheptadin hydrochloride in treatment of mild to moderate failure to thrive in children who referred to clinics of Shiraz University of Medical Sciences at 1390
Public title
The effect of cyproheptadine on pediatric growth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children aged between2 to 5 years old and have mild to moderate failure to thrive. Exclusion criterion: Having organic causes or acute or chronic diseases.
Age
From 2 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2011-11-05, 1390/08/14
Ethics committee reference number
CT-90-5795

Health conditions studied

1

Description of health condition studied
Failure to thrive
ICD-10 code
R62.8
ICD-10 code description
Other lack of expected normal physiological development

Primary outcomes

1

Description
Weight
Timepoint
At begining of study, 1 month after begining and 1 month after termination of study
Method of measurement
Kilogram

2

Description
Height
Timepoint
At begining of study, 1 month after begining and 1 month after termination of study
Method of measurement
Cm

Secondary outcomes

1

Description
Drowsiness
Timepoint
During drug consumption
Method of measurement
History and Physical examination

2

Description
Restlessness
Timepoint
During drug consumption
Method of measurement
History and Physical Examination

Intervention groups

1

Description
Cyproheptadine 0.25 mg/kg/day (twice daily) for 1 month
Category
Treatment - Drugs

2

Description
Multivitamine, 0.25 mg/kg/d(twice daily) for 1 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. GholamReza Haatam
Street address
Zand street, Central structre of SUMS
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Sadat Najib
Position
Assistant Professor of pediatrics
Other areas of specialty/work
Street address
Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1647 4298
Fax
Email
nzahrasan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Sadat Najib
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1647 4892
Fax
Email
nzahrasan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz medical college
Full name of responsible person
Khadijeh Sadat Najib
Position
Assistant Professor of pediatrics
Other areas of specialty/work
Street address
Nemazee Hospital
City
Shiraz
Postal code
Phone
+7 116474892
Fax
+98 71 1647 4892
Email
nzahrasan@yahoo.comebrahimfz@yahoo.com
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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