A Parallel-Group, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of a Zinc-Containing Dietary Supplement (Biolizin) in Improving Functional Poor Appetite in Children Aged 6 to 36 Months
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Children's Eating Behaviour Questionnaire (CEBQ) Composite Total Score from Baseline to Day 42
研究概览
简要总结
Functional poor appetite is common in young children and may be linked to suboptimal micronutrient intake and feeding behavior. This study evaluates whether a zinc-containing oral supplement (Biolizin syrup) can improve eating behavior in children aged 6 to 36 months who have poor appetite without an identifiable medical cause. Participants are followed for 42 days with clinic visits at Day 0, Day 7, Day 21, and Day 42. Caregivers complete validated questionnaires about feeding difficulties and eating behavior; the child's weight and length/height are measured at each visit. Safety is assessed through review of adverse events and routine laboratory tests; serum zinc may be measured according to the protocol. The primary outcome is the change from baseline to Day 42 in the total score of a validated feeding-difficulty scale. Secondary outcomes include changes in Children's Eating Behaviour Questionnaire (CEBQ) subscales, WHO growth indices, serum zinc (if measured), and overall safety
详细描述
Poor appetite in toddlers often reflects a combination of nutritional and behavioral factors. Zinc is an essential trace element that contributes to taste perception, mucosal integrity, and appetite regulation; suboptimal zinc status may exacerbate reduced intake and feeding problems. Biolizin is an oral zinc-containing supplement intended to support appetite and healthy feeding behavior in young children. The study aims to determine whether the supplement, provided together with standardized caregiver counseling on responsive feeding practices, improves caregiver-reported feeding difficulty and eating behavior over 42 days. After consent and screening, eligible children attend visits at Day 0, Day 7 (±2), Day 21 (±3), and Day 42 (±4). At each visit, clinicians review medical history and concomitant treatments, record anthropometrics, and caregivers complete a validated Vietnamese feeding-difficulty scale (0-24, higher scores indicate worse difficulty) and the CEBQ subscales. The study product is taken orally per age-based dosing specified in the protocol; adherence is checked using dosing diaries and returned bottle counts where applicable. Safety laboratories (e.g., complete blood count, liver and renal chemistry) are planned at baseline and Day 42; serum zinc may be obtained according to protocol. Adverse events are collected from consent through Day 42 and are managed according to clinical judgment; expected reactions are generally mild (for example, gastrointestinal discomfort, taste changes, or rash). Source data are recorded in case report forms and entered into a secure database with audit trails, and only de-identified data are used for analysis or sharing. The study has ethics approval and written informed consent is obtained from caregivers before any procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Not applicable (open-label)
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 36 months at screening.
- •Functional poor appetite for ≥2 weeks with at least one of the following:
- •Clearly reduced intake versus usual (lower amount of food and/or fewer meals per day);
- •Prolonged meal duration (>30 minutes per meal);
- •Refusal or avoidance of familiar foods previously accepted;
- •Oppositional feeding behaviors (turning away, crying, gagging/retching, prolonged food holding, lack of cooperation during meals).
- •No obvious organic cause of poor appetite (e.g., acute infection, gastrointestinal/metabolic disease).
- •Weight not below -2 SD compared with WHO growth standards.
- •Parent/guardian provides written informed consent.
排除标准
- •Ongoing acute or chronic illnesses that can affect intake or absorption, including but not limited to:
- •Acute infections (e.g., tonsillitis, pneumonia, otitis media, viral febrile illness, acute diarrhea);
- •Chronic conditions affecting digestion or metabolism (e.g., celiac disease, malabsorption syndromes, chronic liver disease, chronic kidney disease, diabetes).
- •Neurodevelopmental or neurological conditions that impair feeding (e.g., cerebral palsy, autism spectrum disorder, global developmental delay).
- •Current or recent use of medications known to alter appetite or digestion/absorption (e.g., systemic corticosteroids, antiepileptics, prolonged antibiotics).
- •Use of zinc-containing products or other appetite stimulants within 7 days before screening.
- •Known hypersensitivity to any component of the study product.
- •Malabsorption, severe malnutrition, or requirement for specialized nutrition, including:
- •Confirmed or suspected malabsorption (e.g., celiac disease, severe lactose intolerance, short bowel syndrome, inflammatory bowel disease);
- •Severe malnutrition per WHO criteria (e.g., weight-for-length Z-score < -3 SD, nutritional edema, marked loss of subcutaneous fat/muscle);
- •Physician-prescribed specialized nutrition plans (therapeutic formulas for cow's milk protein allergy, severe malnutrition, tube feeding, or individualized nutrition regimens beyond usual diet).
- •Nonadherent caregiver or high risk of loss to follow-up as judged by the investigator.
研究组 & 干预措施
Biolizin Syrup + Standardized Caregiver Counseling
Children receive an oral zinc-containing dietary supplement (Biolizin syrup) for 42 days, dosed by age per protocol, together with standardized caregiver counseling on responsive feeding at each study visit (Day 0, Day 7, Day 21, Day 42). Adherence is monitored with dosing diaries and returned bottle counts. Use of other zinc-containing products or appetite stimulants is not permitted. Outcomes (feeding-difficulty score, CEBQ subscales, anthropometrics, and safety labs) are collected per schedule
干预措施: Biolizin (Dietary Supplement)
Biolizin Syrup + Standardized Caregiver Counseling
Children receive an oral zinc-containing dietary supplement (Biolizin syrup) for 42 days, dosed by age per protocol, together with standardized caregiver counseling on responsive feeding at each study visit (Day 0, Day 7, Day 21, Day 42). Adherence is monitored with dosing diaries and returned bottle counts. Use of other zinc-containing products or appetite stimulants is not permitted. Outcomes (feeding-difficulty score, CEBQ subscales, anthropometrics, and safety labs) are collected per schedule
干预措施: Standardized caregiver counseling on responsive feeding (Behavioral)
Counseling Only (Standardized Feeding-Behavior Counseling)
Children receive the same standardized caregiver counseling on responsive feeding at each study visit (Day 0, Day 7, Day 21, Day 42) without Biolizin or any other zinc-containing supplement. Education materials, visit frequency, and assessments match the experimental arm. Concomitant appetite stimulants or zinc products are not allowed. Outcomes are collected per the same schedule.
干预措施: Standardized caregiver counseling on responsive feeding (Behavioral)
结局指标
主要结局
Change in Children's Eating Behaviour Questionnaire (CEBQ) Composite Total Score from Baseline to Day 42
时间窗: Baseline to Day 42
The CEBQ is a validated parent-reported questionnaire assessing eating behaviors in children. Each item is scored from 1 (never) to 5 (always). The composite total score is derived from multiple domains (range: 1-5). Higher scores indicate more adverse eating behaviors (worse outcome). A negative change (Day 42 - Baseline \< 0) indicates improvement.
Change in Children's Eating Behaviour Questionnaire (CEBQ) Food Approach Behaviors from Baseline to Day 42
时间窗: Baseline to Day 42
The Children's Eating Behaviour Questionnaire (CEBQ) is a validated parent-reported questionnaire assessing eating behaviors in children. The "food approach" score is the mean of four subscales: Enjoyment of Food, Food Responsiveness, Emotional Overeating, and Desire to Drink. Each item is scored from 1 (never) to 5 (always). Subscale scores range from 1-5, with higher values indicating greater food approach behaviors (worse outcome). A negative change indicates improvement.
Change in Children's Eating Behaviour Questionnaire (CEBQ) Food Avoidant Behaviors from Baseline to Day 42
时间窗: Baseline to Day 42
Mean change in Children's Eating Behaviour Questionnaire (CEBQ) "food avoidant" subscales (Satiety Responsiveness, Slowness in Eating, Food Fussiness, Emotional Undereating). Lower scores indicate less avoidance; negative change denotes improvement.
Responder Rate on Children's Eating Behaviour Questionnaire (CEBQ) (≥30% Improvement) at Day 42
时间窗: Day 42
Proportion of participants achieving ≥30% decrease from baseline in the pre-specified Children's Eating Behaviour Questionnaire (CEBQ) adverse-behavior composite (per SAP).
次要结局
- Change in Hoang Thi Bach Yen Anorexia Scale (Vietnamese Caregiver-Reported Pediatric Anorexia Scale) Total Score from Baseline to Day 42(Baseline to Day 42)
- Change in Body Weight from Baseline to Day 42(Baseline to Day 42)
- Change in Number of Daily Meals from Baseline to Day 42(Baseline to Day 42)
- Change in Mean Meal Duration from Baseline to Day 42(Baseline to Day 42)
- Change in Caregiver-Rated Cooperation During Meals Scale Score from Baseline to Day 42(Baseline to Day 42)
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)(From first dose to Day 42)
- Change in Serum Zinc Concentration from Baseline to Day 42(Baseline to Day 42)
- Change in Body Length/Height from Baseline to Day 42(Baseline to Day 42)