Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Number of Antigen-presenting B Cells
研究概览
简要总结
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Days 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy term infants
- •birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)
- •receiving >80% for their intake by mouth from commercial infant formula
- •low-risk for allergy based on a negative family history.
排除标准
- •corticosteroid use
- •red cell or plasma transfusions
- •IV lipid emulsions prior to study entry
- •major congenital malformations
- •systemic or congenital infection
- •significant neonatal morbidity
- •maternal autoimmune disorders
- •acute illness precluding oral feedings or conditions requiring feedings other than standard formula
研究组 & 干预措施
34 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
干预措施: Arachidonic acid (34 mg/100 kcal) (Dietary Supplement)
25 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
干预措施: Arachidonic acid (25 mg/100 kcal ) (Dietary Supplement)
Infant formula without arachidonic acid
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of Antigen-presenting B Cells
时间窗: 10 weeks
次要结局
未报告次要终点