A study of an oral nutritional supplementation in picky eating children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 321
- 试验地点
- 8
- 主要终点
- Change in WHO weight-for-height percentile from Day 1 to Day 90
研究概览
简要总结
When the rapidly growing child consumes a limitedquantity and/or variety of foods, there may be significant health consequences.Periods of variable duration characterized by poor appetite, inappropriatefoods for age and/or food refusal are observed in healthy children. Eatingproblems in children are common concerns of parents and the severity of thesefindings vary widely, from failure to gain weight and height to loss of bodyweight. “Picky eating†is a relatively common problem during childhood rangingfrom 8% to 50% of children in different published studies.Itis characterized by the toddler or child eating a limited amount of food,restricting intake particularly of vegetables, being unwilling to try newfoods, and having strong food preferences often leading parents to providetheir child a meal different from the rest of the family.Pickyeaters consume inappropriate quantities of total fats, energy and proteins thanchildren never reporting picky eating behaviour,and this can predispose the child to nutritional deficiencies. Ifthe poor feeding behavior is severe enough to cause growth faltering, long termgrowth and development can be negatively affected.It can alsolead to increased susceptibility to infections. Children who are unable tomaintain adequate energy and nutrient intake require modifications in theirfeeding habits and oral nutritional supplements may be indicated and effective.Food and nutrition programs may help to achieve the goal of providingsafe and healthy nutrition to children at risk
Nutritional supplementation may prove beneficial forproper growth and development in pediatric patients. The goal ofthe present study is to compare the efficacy and safety of two pediatric oralnutritional supplements along with dietary counseling vs dietary counselingalone on the growth of preschool children in India.
Study will be published in the journal (national / international) after completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 24.00 Month(s) 至 48.00 Month(s)（—）
- 性别
- All
入选标准
- •Child is > 24 months and ≤ 48 months of age at visit
- •Child of either gender (Male and Female).
- •Child has a weight-for-height between 3rd – 15th percentiles according to current WHO Growth Charts at visit
- •(WHO Growth Chart 2007) 4)Child is a picky eater, defined as meeting at least two of the following criteria.
- •A child, who a.eats only a limited number of foods b.is unwilling to try new foods c.refuses to eat vegetables and/or foods from other food groups d.shows strong food likes and dislikes e.has behaviors that disrupt mealtime 5)Child is a habitual milk drinker at least 1 glass (approx.
- •200ml) of milk daily.
- •Child is able to consume foods and beverages orally.
- •Child’s LG or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period.
- •Child’s LG or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
- •Child’s LG or parent(s) is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
- •Child’s LG or parent(s)is not planning to relocate during the study period.
排除标准
- •Child has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or LG/parent report.
- •Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or LG/parent report.
- •Child has a current acute or chronic infection including but not restricted to respiratory infection, diarrhea, Hepatitis B or C, HIV infection or tuberculosis according to medical records or LG/parent report based on the clinician’s judgment.
- •Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or LG/parent report.
- •Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or LG/parent report.
- •Child has been diagnosed with hormonal or metabolic disorders according to medical records or LG/parent report.
- •Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down’s syndrome according to medical records or LG/parent report.
- •Child has been diagnosed with infantile anorexia nervosa according to medical records or LG/parent report.
- •Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or LG/parent report.
- •Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
- •Child has any other clinically significant medical condition, which in the investigator’s opinion, makes him or her unsuitable for inclusion in the study.
结局指标
主要结局
Change in WHO weight-for-height percentile from Day 1 to Day 90
时间窗: Change in WHO weight-for-height percentile from Day 1 to Day 90
次要结局
- –Change in weight-for-height WHO z-score.(–Change in weight-for-age WHO z-score and percentile.)