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

University of Indonesia (UI)

Status: Completed

Conditions: Appetite Loss

Treatments: Drug: cyproheptadine hydrochloride; Other: Giving placebo divided by 2 dose every 12 hours for 4 weeks.

Study type: Interventional

Funder types: Other

Identifiers

NCT07006181

24081215

Details and patient eligibility

About

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)

Full description

This study was conducted in a hospital in the Jakarta region, RS Citra Arafiq. All patients who met the inclusion criteria and had informed consent will be assessed for appetite scoring (ECAST) by the research team and diet analysis as a patient baseline before conducting research. Scoring of appetite and daily calorie achievement was carried out by the team researcher. All patients underwent anthropometric measurements (body weight, height) carried out by the team.

The intervention was carried out for 4 weeks, divided into two groups randomly. During the intervention, caregivers are asked to carry out daily observations and recordings regarding food intake (food records) and weighing 2nd week, 4th week and 8th week. Every patient who meets the inclusion criteria receives education regarding correct feeding rules. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).

Enrollment: 44 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criterias:

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

Exclusion criterias:

1. Major congenital abnormalities
2. CNS disorders (Cerebral palsy)
3. Inborn errors of metabolism (IEM)
4. GERD (Gastro esophageal reflux disease)
5. Severe acute malnutrition

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups, including a placebo group

Cyproheptadine hydrochloride

Experimental group

Description:

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

Treatment:

Drug: cyproheptadine hydrochloride

Control group

Placebo Comparator group

Description:

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

Treatment:

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