A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in Preschool Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 20
- 主要终点
- Peabody Picture Vocabulary Test
研究概览
简要总结
The primary objective of this study is to determine whether a 4-month period of supplementation with 400 mg/day of docosahexaenoic acid (DHA) provided from chewable softgel capsules containing bubblegum flavored microalgal oil (DHASCO-S) versus placebo improves one or more cognitive measures of attention, memory, processing speed, and error rate in healthy children 4 years of age.
The secondary objectives are to measure the safety and tolerability of the DHA dose administered and to measure blood DHA levels before and after supplementation.
详细描述
DHA is the primary omega-3 fatty acid present in the brain and retina and plays crucial structural and functional roles in these issues. The primary dietary source of DHA is fatty fish (e.g., salmon, herring, tuna). The American diet provides one of the lowest levels of omega-3 fatty acids of most industrialized nations. Children between the ages of 1 and 5 years consume only 30 to 50 mg DHA per day despite high requirements for this nutrient to support growth and tissue turnover.
Studies with human infants have reported visual and cognitive benefits of DHA supplementation in early life. Reported benefits include significant improvements on tests of visual acuity during infancy, psychomotor or mental development in the first two years of life, and problem-solving and sustained attention around 5 years of age.
Few studies have evaluated the effect that DHA supplementation has on the cognitive function of older children. Studies that considered DHA supplementation in children 4-12 years of age with attention-deficit/hyperactivity disorder (ADHD) or other developmental disorders have shown improvements on several measures of attention, behavior, and executive function.
Given the estimated high requirements of DHA to support growth and maintenance of the brain, the low consumption of DHA by American children, and the evidence from human and animal studies that DHA status affects the functional capacity of the central nervous system, there is a reasonable expectation that DHA supplementation administered to preschool-aged children will improve performance on tests of attention, memory, processing speed, and error rate.
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
- Double
入排标准
- 年龄范围
- 4 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age at enrollment between 4 years 0 months and 4 years 8 months
- •Height and weight between the 10th and 90th percentiles of the National Center for Health Statistics (NCHS) growth charts
- •Subject must meet normal developmental milestones.
- •Subject able to understand instructions provided during the cognitive testing, i.e. English must be the primary language in the home
- •No evidence of a medical condition that would preclude successful response or outcome (e.g., uncorrected vision or hearing impairment, attention deficit disorder, or inborn error of metabolism)
- •Not taking any medications for seizure disorder, anxiety disorders (e.g., Valium or related compounds), ADHD (e.g., Ritalin, Adderall, Concerta, Strattera, or similar medication), childhood psychosis (e.g., Haldol, Risperdal), depression (e.g., Prozac), or for bipolar disorder. A subject will not be withdrawn from the trial if he/she needs to take one of these medications after enrollment. Antihistamines (e.g., Benadryl or other antihistamines) should not be administered within 24 hours of the day of the cognitive exams (Claritin or Allegra are allowed). If a subject is taking an antihistamine on the day of the cognitive tests, the tests will be rescheduled.
排除标准
- •Premature birth (< 36 weeks gestation)
- •Family history of ADHD
- •Subject consumes > 3 oz. of fish more than 2 times per week.
- •Subject consumes dietary supplements or foods containing or fortified with omega-3 fatty acids.
- •Subject received any investigational product within the past 30 days.
- •Subject having any medical condition that in the opinion of the principal investigator would preclude a successful response or outcome (e.g., uncorrected vision or hearing impairment, attention deficit disorder or inborn error of metabolism)
结局指标
主要结局
Peabody Picture Vocabulary Test
Day-Night Stroop Test
Kiddie Continuous Performance Test (kCAP)
Leiter Test of Sustained Attention
次要结局
- Safety and tolerability of the DHA dose
- Blood DHA levels before and after DHA supplementation