Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- change in vitamin C status
研究概览
简要总结
This study compares the status of key micronutrients (vitamins A, C, D, E, and zinc) in young children given investigational fortified milk versus young children consuming their habitual pattern of beverage intake (milk and non-milk beverages).
详细描述
Hypothesis that Vitamin A, C, D, E and zinc status of children consuming 2 servings / day of fortified milk for 16 weeks will be better than those of children consuming their habitual pattern of beverage intake (milk and non-milk beverages, juices, sugar-sweetened drinks) for the same duration. This is based on previous study findings that (i) the toddler's and preschooler's diet, in reality, are often not optimal, putting toddlers and preschool age children at risk of insufficient intakes of several nutrients, and (ii) consuming fortified milk supplemented with these nutrients might provide optimal intakes of these nutrients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 36 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
- •Child's parent(s)/guardian is/are of legal age of consent, must understand the informed consent and other study documents, and is/are willing and able to fulfill the requirements of the study protocol
- •Age 3 years old to 4 years old and 6 months at enrolment
- •Healthy at birth, singleton, full-term gestational birth (37-42 completed weeks of gestation), with a birth weight of 2.5 kg to 3.9 kg
- •At the time of enrolment, the participant's weight-for-age, height-for-age, weight-for-height, BMI z-score should be within -2 to +1
- •At the time of enrolment, the participant is in good health (no history of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the child to ingest food, the normal growth and development of the child, or the evaluation of the infant; acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot & mouth disease at time of enrolment is permitted) as determined by physical history, physical exam and judgement by the investigator
- •Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study
排除标准
- •Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures
- •Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin < 100 g/L based on screening assessment, rickets based on physical exam).
- •Known or suspected cows' milk protein intolerance / lactose intolerance /allergy or severe food allergies that impact diet
- •Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age
- •Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc
- •Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
结局指标
主要结局
change in vitamin C status
时间窗: 16 weeks
measure in plasma vitamin C in mg/dL
change in vitamin E status
时间窗: 16 weeks
measure in plasma alpha-tocopherol in mg/L
change in vitamin A status
时间窗: 16 weeks
measure in serum retinol in μmol/L
change in vitamin D status
时间窗: 16 weeks
measure in serum 25-hydroxy vitamin D (25\[OH\]D) in nmol/L
change in zinc status
时间窗: 16 weeks
measure in plasma zinc in μg/dl
次要结局
- assess dietary intake(4 weeks, 8 weeks, 12 weeks, 16 weeks)
- nucleotides status assessment(16 weeks)
- assess child developmental milestones(16 weeks)
- assess fortified milk acceptability(4 weeks, 8 weeks, 12 weeks, 16 weeks)
- monitor absenteeism from day care or pre-school due to illness(16 weeks)
- monitor concomitant medication (CM) reporting(16 weeks)
- assess habitual pattern of food and beverage intake(16 weeks)
- monitor standard adverse events (AE)(16 weeks)
- monitor growth and development(16 weeks)