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Comparing the effect of low dose and standard dose Cyproheptadine on BMI enhancement in children aged 2-10 and evaluation of its side effects

Protocol summary

Study aim
In case of lower dose efficiency on the body mass index (BMI), this dose can be replaced , which will impose fewer side effects on the patient and increase the drug acceptance by the patient.
Design
A clinical trial with a control group, with factorial groups, double-blind, randomized, phase 4 on 90 patients, randomization with permutation blocks.
Settings and conduct
This double-blind clinical trial study on children aged 2 to 10 years, whose BMI Z-score is less than -2 standard deviation (Z-score<-2 standard deviation) of the BMI chart according to age and sex, and the entry criteria for This study is being done. This study will be conducted in Imam Ali (AS) Shahrekord Clinic. The study will be conducted in three groups including low dose cyproheptadine (group 1), standard dose cyproheptadine (group 2) and control (group 3). The sample size for each group was 30 people. The dose of cyproheptadine in group 1 will be 1 mg every night for 2 to 5 years and 2 mg every night for 5 to 10 years, according to the age of the child. The dose of cyproheptadine in group 2 will be 2 mg every 12 hours for 2 to 5 years and 4 mg every 8 hours for 5 to 10 years. The duration of the study will be 4 months and the follow-ups will be in person and monthly. In each visit, clinical information and drug side effects will be recorded in the checklist.
Participants/Inclusion and exclusion criteria
Children aged 2 to 10 whose BMI is less than -2 SD in the BMI chart according to age and sex. These children should not have a pathological cause for thinness. These children should not be receiving any other treatment in this area.
Intervention groups
After randomization, the sample will be divided into three groups including group 1 (cyproheptadine low dose), group 2 (cyproheptadine with standard dose) and group 3 (control).
Main outcome variables
Height(to calculate BMI), weight, BMI, drug side effects separatly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240213060992N1
Registration date: 2024-07-20, 1403/04/30
Registration timing: prospective

Last update: 2024-07-20, 1403/04/30
Update count: 0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Negar Javidmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3364 7459
Email address
negarjavidmehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-26, 1403/05/05
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of low dose and standard dose Cyproheptadine on BMI enhancement in children aged 2-10 and evaluation of its side effects
Public title
Comparing the effect of low dose and standard dose Cyproheptadine on BMI enhancement in children aged 2-10 and evaluation of its side effects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of the child's guardian to participate in the study Being aware and vigilant of the guardian of the child Age 2 to 9 years and 6 months at the first visit BMI Z-score is less than -2 standard deviations in the BMI table according to age and sex of the CDC, which is set based on 15day intervals.
Exclusion criteria:
Celiac disease, Crohn's disease, sensitivity to cow's protein, hypothyroidism, hyperthyroidism, congenital megacolon, eosinophilic gastroenteritis, cystic fibrosis and any disease that causes malabsorption. Allergy to antihistamines Consumption of other appetite stimulants and multivitamins and zinc in the study Treatment with growth hormone, gonadotropin-releasing hormone analog, aromatase inhibitors, recombinant human-like growth factor and androgen in the study Entering stage 1 of puberty including the enlargement of testicles in boys, growth of pubic hair in boys, breast enlargement in girls
Age
From 2 years old to 10 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
After randomization, the sample will be divided into three groups including group 1 (cyproheptadine low dose), group 2 (cyproheptadine with standard dose) and group 3 (control). In order to randomly allocate people, the permutation block method will be used with a volume of 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the random allocation of people, the permutation block method will be used with a volume of 6, and the randomization list will be provided to a person who does not know about the content of the interventions. The substance under study, both drug and placebo, will be coded, and only the person informed of the randomization list will know about the relationship between the code and the substance. The doctor will remain unaware of the group of patients and will only know about the code assigned to each patient. Also, the information of the groups under the title of group A, B and C will be presented to the statistical analyzer.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, shahrekord, iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2023-07-22, 1402/04/31
Ethics committee reference number
IR.SKUMS.MED.REC.1402.026

Health conditions studied

1

Description of health condition studied
thinness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination and comparison of average BMI changes in the groups under investigation in repeated measurements during the study period
Timepoint
The start of the study, one month, two months, three months and four months after the start of the study
Method of measurement
Scale and meter, the measurement accuracy for weight will be 0.1 kg and for height 0.1 cm. To measure height and weight, the child will be without shoes.

2

Description
Determining the percentage of side effects caused by cyproheptadine consumption (drowsiness, irritability, headache, nausea, diarrhea, restlessness, moodiness, muscle weakness, constipation, insomnia, skin rash) in repeated measurements during the study period.
Timepoint
The start of the study, one month, two months, three months and four months after the start of the study
Method of measurement
The researcher-made checklist includes drug complications based on the NIH criteria, asking parents and recording the presence or absence of complications

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: low dose cyproheptadine , children aged 2 to 5 years will receive 2.5 ml of oral solution of 2 mg/5 ml terzamine solution of Amin pharmaceutical company every night. The age group of 2 to 5 years will be given a measuring unit of 2.5 ml and parents will be taught how to use it. For the age of 5 to 10 years, half a 4 mg cyproheptadine tablet of Darupakhsh company will be prescribed every night. Therefore, the dose of cyproheptadine in this group for the age of 2 to 5 years will be 1 mg every night and for the age of 5 to 10 years, 2 mg every night.
Category
Treatment - Drugs

2

Description
Intervention group2: Standard dose cyproheptadine, children 2 to 5 years old, every 12 hours will receive 5 ml of oral solution of 2 mg/5 ml terzamine solution of Amin Pharmaceutical Company. In this group, children aged 5 to 10 will receive a 4 mg cyproheptadine tablet every 8 hours. Therefore, the drug dose in the second group for children aged 2 to 5 years will be 2 mg every 12 hours and for children aged 5 to 10 years, 4 mg every 8 hours.
Category
Treatment - Drugs

3

Description
Control group: placebo,children 2 to 5 years old will receive 2.5 ml of placebo solution every night in the same container as cyproheptadine solution. Also, a placebo tablet will be prescribed every night for children aged 5 to 10 years.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Negar Javidmehr
Street address
Imam Ali clinic, Shariati Ave
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
1111111111
Phone
+98 910 358 3899
Email
javidmehrnegar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Shahrekord University of Medical Sciences
Street address
University Headquarters, Kashani Blvd
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 910 358 3899
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Negar Javidmehr
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.5, Janbazan Ave, Azadegan Blvd
City
Esfahan
Province
Isfehan
Postal code
8415634561
Phone
+98 31 3364 7459
Fax
Email
negarjavidmehr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hassan Talakesh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
The headquarters of the University of Medical Sciences,Kashani Blvd
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
038333300617
Email
hassan.talakesh2013@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hassan Talakesh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
The headquarters of the University of Medical Sciences,Kashani Blvd
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
038333300617
Email
javidmehrnegar@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The file of checklist where age, sex, height, weight, background disease and possible drug side effects can be published.
When the data will become available and for how long
starting 3 months after publication
To whom data/document is available
All researchers
Under which criteria data/document could be used
State the objectives of their study Respecting the rights of authors
From where data/document is obtainable
hassan.talakesh2013@gmail.com javidmehrnegar@gmail.com
What processes are involved for a request to access data/document
The content of the email should include the requested items with details, the objectives of their study and how to respect the authors' rights. After examining their request, the author's response, either agreement or disagreement, will be sent to them as soon as possible.
Comments
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