Appetite Loss
Conditions
Keywords
Cyproheptadine hydrochloride, appetite loss, children, mild malnutrition
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)
Detailed 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).
Interventions
Giving Cyproheptadine hydrochloride 0.25 mg/kg/day divided by 2 dose every 12 hours for 4 weeks.
OTHERGiving placebo divided by 2 dose every 12 hours for 4 weeks.
Giving placebo divided by 2 dose every 12 hours for 4 weeks.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
s: 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 criteria
s: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECAST children's appetite scoring | From enrollment, then 4 weeks to the end of treatment at 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric status | From enrollment, then 4 weeks to the end of treatment at 8 weeks | The patient's nutritional status is based on the patient's body weight ratio in kilograms to height in centimeters at when collecting research data, according to the standard deviation value WHO 2006 growth curve in weight for length type according to gender. Weighing weight and height using digital scales and infantometer/stadiometer. |
| Calorie intake | From enrollment, then 4 weeks to the end of treatment at 8 weeks | The average number of calories achieved by the children was compared with the child's calorie needs per day. |
Countries
Indonesia
Outcome results
None listed