Effectiveness of Cyproheptadine Hydrochloride Against Appetite to Improve Children's Nutritional Status

NCT07006181 | Completed DMC

• 1 other identifier: 24081215
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the benefits of Cyproheptadine hydrochloride in increasing appetite as well as its effect on weight gain in children aged 1-5 years who have difficulty eating. The main questions it aims to answer are:

• Is Cyproheptadine hydrochloride useful in increasing appetite in children?
• Is the Cyproheptadine hydrochloride dose given effective and efficient regarding the improvement of a child's appetite? Can giving Cyproheptadine hydrochloride improve nutritional status of children?
• How long can Cyproheptadine hydrochloride be given to increase appetite in children and what are the side effects? Participants will:
• Take the Cyproheptadine hydrochloride every day, twice a day for 4 weeks (intervention group); take the placebo (control group)
• Have their ECAST score (score for measuring appetite in children), anthropometric measurement before and after intervention at the second visit (2 weeks), third visit (4 weeks and stop intervention), and fourth visit (8 weeks after stopping the intervention)

Conditions

Appetite Loss

Keywords

Cyproheptadine hydrochloride; appetite loss; children; mild malnutrition

Outcome Measures

Primary Outcomes (1)

• ECAST children's appetite scoring

  ECAST children's appetite questionnaire parameters have been modified into 16 questions and have been validated and implemented. This instrument is about a child's appetite ask most parents or caregivers understand the child's condition at all times. The results of this questionnaire will compared with the average daily calorie achievement. Responses to this instrument were coded as: 1 for "never", 2 for "sometimes" and 3 for "often". The total ECAST score is obtained by summing the responses and a higher score indicates a greater appetite.

  From enrollment, then 4 weeks to the end of treatment at 8 weeks

Secondary Outcomes (2)

• Anthropometric status

  From enrollment, then 4 weeks to the end of treatment at 8 weeks

• Calorie intake

  From enrollment, then 4 weeks to the end of treatment at 8 weeks

Study Arms (2)

Cyproheptadine hydrochloride

EXPERIMENTAL

Giving Cyproheptadine hydrochloride dossage 0.25 mg/kg/day divided by 2 dose every 12 hours for 4 weeks.

Drug: cyproheptadine hydrochloride

Control group

PLACEBO COMPARATOR

Giving placebo and divided by 2 dose every 12 hours for 4 weeks.

Other: Giving placebo divided by 2 dose every 12 hours for 4 weeks.

Interventions

cyproheptadine hydrochloride DRUG

Giving Cyproheptadine hydrochloride 0.25 mg/kg/day divided by 2 dose every 12 hours for 4 weeks.

Cyproheptadine hydrochloride

Giving placebo divided by 2 dose every 12 hours for 4 weeks. OTHER

Giving placebo divided by 2 dose every 12 hours for 4 weeks.

Control group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Experiencing decreased appetite and/or difficulty eating
• Poor nutritional status and/or weight faltering
• The parents agree to participate in the research by signing an informed consent.
• Patients have National Health Insurance or other health insurance.

You may not qualify if:

• Major congenital abnormalities
• CNS disorders (Cerebral palsy)
• Inborn errors of metabolism (IEM)
• GERD (Gastro esophageal reflux disease)
• Severe acute malnutrition

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Citra Arafiq Hospital

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Anorexia

Interventions

Cyproheptadine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Doctoral Program in Nutritional Sciences, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 5, 2025
• Study Start: November 4, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05

Locations

ID (1)