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

Phase 4

Conditions: thinness.

Registration Number: IRCT20240213060992N1

Lead Sponsor: Shahre-kord University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 90

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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 Outcome Measures