NCT05266677撤回不适用
Effect of a Liquid Oral Supplement Comprising a Blend of Glycerides at Certain Proportions on Infant and Toddler DHA Status
Société des Produits Nestlé (SPN)0 个研究点开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- RBC-DHA levels after 56 days of supplementation
研究概览
简要总结
This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain proportions on infant and toddler DHA status.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 14 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who fulfil all of the following inclusion criteria will be included:
- •Evidence of personally signed and dated informed consent form indicating that the infant/toddler's parent(s)/ Legally Authorized representative (LAR) has been informed of all pertinent aspects of the study.
- •Infants/toddlers whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- •Infants/toddlers must meet the following inclusion criteria respectively to be eligible for enrollment into the study:
- •Healthy normally developing infant/toddler at the discretion of the investigator.
- •Healthy term infant (37-42 weeks of gestation) at birth.
- •At enrollment visit, post-natal age 2-3 months (60-90 days) for infants or 13-14 months for toddlers (date of birth = day 0).
- •For the infant group, infants must have been exclusively consuming and tolerating a cow's milk infant formula not containing DHA for the past month, and their parent(s)/LAR must have independently elected, before enrolment, not to breastfeed.
- •For the toddler group, toddlers must have been consuming and tolerating a cow's milk TMS not containing DHA for the past month.
- •Infants or toddlers must not have been consuming DHA-containing supplements for the past month.
排除标准
- •Any of the following criteria would render a subject ineligible for inclusion:
- •Infants/toddlers with conditions requiring feedings other than those specified in the protocol.
- •Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 grams (g) per day of complementary foods or liquids at enrollment.
- •Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- •Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
- •Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
- •Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal (e.g., complicated gastroesophageal reflux combined with inadequate growth and/or respiratory complications, Hirschsprung's disease), or other systemic diseases.
- •History of admission to the Neonatal Intensive Care Unit, with the exception of admission for jaundice phototherapy.
- •Currently participating or having participated in another clinical trial since birth.
- •Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant/toddler inappropriate for entry into the study.
- •Infants/toddlers who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., lactase enzymes, pancreatic enzymes); medications that may neutralize or suppress gastric acid secretion; medications that could affect any study outcomes.
- •Infants/toddlers whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
结局指标
主要结局
RBC-DHA levels after 56 days of supplementation
时间窗: Study day 56
Red blood cell (RBC)-DHA after eight weeks of intervention
次要结局
- DHA supplement intake(Study days 3, 14, 28 and 56)
- Weight(Study days 0, 14, 28 and 56)
- Gastrointestinal (GI) tolerance(Study days 3, 14, 28 and 56)
- Dietary intakes of DHA and other fatty acids (toddler population only)(Study days 0, 28 and 56)
- Standard adverse events (AEs) and serious AEs (SAEs) reporting for safety assessment(Study days 0, 14, 28, 56, and 70)
- RBC, plasma additional fatty acids status(Study days 0, 14, 28 and 56)
- Length(Study days 0, 14, 28 and 56)
- Head circumference(Study days 0, 14, 28 and 56)
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