Actively Recruiting
A Parallel-Group, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Biolizin, a Zinc-Containing Supplement, in Improving Functional Poor Appetite in Children Aged 6 to 36 Months
Led by Haiphong University of Medicine and Pharmacy · Updated on 2026-01-30
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Poor appetite is common in young children and can affect their nutrient intake and eating behavior. This research aims to evaluate whether a zinc-containing oral supplement called Biolizin syrup can improve eating behavior in children aged 6 to 36 months who have poor appetite without a clear medical cause. The study is randomized and controlled, focusing on changes in feeding difficulty and eating behavior over 42 days. Children in the study receive either Biolizin syrup, taken once or twice daily according to age-based dosing for 42 days along with caregiver counseling on responsive feeding, or they receive only the caregiver counseling without the supplement. Caregivers attend clinic visits at Day 0, Day 7, Day 21, and Day 42 to receive counseling, report feeding behavior, and monitor adherence. Use of other zinc products or appetite stimulants is not allowed. Participants undergo measurements of weight and height at each visit, and caregivers complete validated questionnaires on feeding difficulties and eating behavior. Safety is monitored through adverse event review and laboratory tests at baseline and Day 42, including possible serum zinc levels. The main outcome measured is the change in feeding difficulty score from the start to Day 42. Secondary outcomes include changes in eating behavior subscales, growth indices, serum zinc, and overall safety throughout the study.
CONDITIONS
Brief Title
Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 36 months at screening
- Functional poor appetite lasting 2 weeks or more
- Poor appetite shows as reduced food intake, prolonged meal duration over 30 minutes, refusal of familiar foods, or oppositional feeding behaviors
- No obvious medical cause for poor appetite such as acute infection or metabolic disease
- Weight not below -2 standard deviations compared with WHO growth standards
- Parent or guardian provides written informed consent
You will not qualify if you...
- Acute or chronic illnesses affecting intake or absorption, including infections (tonsillitis, pneumonia, otitis media, viral illness, diarrhea) or chronic diseases (celiac disease, liver or kidney disease, diabetes)
- Neurodevelopmental or neurological disorders impairing feeding (cerebral palsy, autism spectrum disorder, developmental delay)
- Current or recent use of medications affecting appetite or digestion such as corticosteroids, antiepileptics, or antibiotics
- Use of zinc-containing products or appetite stimulants within 7 days before screening
- Known allergy to any component of the study product
- Malabsorption, severe malnutrition, or need for specialized nutrition plans
- Caregiver nonadherence or high risk of loss to follow-up as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 42 days
Participants take the Biolizin oral zinc-containing supplement once or twice daily for 42 consecutive days along with standardized caregiver counseling on responsive feeding at each clinic visit. Caregivers complete dosing diaries and adherence is monitored using returned bottle counts. Safety labs and assessments are conducted.
4 visits (in-person) at Day 0, Day 7, Day 21, and Day 42
Trial Site Locations
Total: 1 location
1
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, Vietnam, 180000
Actively Recruiting
Research Team
P
Phuong Thi Thu Nguyen, MD, PhD
A
Anh Van Tran, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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