Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sarah Keim
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- Erythrocyte Fatty Acid Levels (Additional Data)
研究概览
简要总结
The purpose of this study is to examine whether supplementation with certain polyunsaturated fatty acids can help the cognitive development of children born preterm.
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
- 10 Months 至 16 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10-16 completed months (age corrected for prematurity) at baseline
- •Discontinued regular breastfeeding and formula feeding at the time of randomization
- •Gestational age < 35 completed weeks at birth
- •English is primary language in home
- •Informed consent obtained and signed
- •Child admitted to any NCH managed NICU or children who have ever had a Neonatology Clinic follow up visit scheduled, regardless of attendance
排除标准
- •Feeding problems
- •Major malformation, metabolic, or digestive disorder that would preclude participation and/or optimal absorption of the supplement.
- •Weight < 5th or > 95th percentile for age, per WHO growth charts
- •Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than 2x per week
- •Plans to move out of the area within the next 6 months
- •Known corn allergy
- •Known soy allergy
- •Known fish allergy
研究组 & 干预措施
Docosahexaenoic Acid + Arachidonic Acid
Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
干预措施: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) (Drug)
Placebo
Corn oil supplement
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Erythrocyte Fatty Acid Levels (Additional Data)
时间窗: Baseline to 180 days post-randomization
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Adherence
时间窗: Baseline to 180 days post-randomization
The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Erythrocyte Fatty Acid Levels
时间窗: Baseline to 180 days post-randomization
This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc
Enrollment and Trial Completion
时间窗: Baseline to 180 days post-randomization
The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc.
次要结局
- (Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)(Baseline to 180 days post-randomization)
- (Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)(Baseline to 180 days post-randomization)
研究者
Sarah Keim
Principal Investigator
Nationwide Children's Hospital