EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- total plasma fatty acid ARA levels
研究概览
简要总结
The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.
详细描述
This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Weeks 至 26 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •singleton infants,
- •parent of legal age to consent,
- •willing to feed the child the assigned study formula for the treatment duration,
- •parent agrees to scheduled blood draws
排除标准
- •exclusively breastfed or formula-fed beyond 6 months,
- •difficulty swallowing or other congenital malformation or metabolic anomaly,
- •taking omega-3 (supplemented) foods,
- •mother had gestational diabetes or is Type II diabetic,
- •born at <37 weeks gestational age,
- •participating in another study
研究组 & 干预措施
combination ARA+ DHA
combination 0.76% ARA+ 0.4% DHA in infant formula per day
干预措施: combination ARA + DHA (Dietary Supplement)
DHA
0% ARA +0.4% DHA in infant formula per day
干预措施: DHA (Dietary Supplement)
结局指标
主要结局
total plasma fatty acid ARA levels
时间窗: 6 months of supplementation
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
次要结局
- incidence of infections(6 months of supplementation)
- weight gain(6 months of supplementation)
- length gain(6 months of supplementation)
- head circumference(6 months of supplementation)
- dietary intake of ARA(6 months of supplementation)
- plasma levels of immune markers(6 months of supplementation)