NCT01897948终止不适用
The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children
Mead Johnson Nutrition2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid
研究概览
简要总结
This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 3 Years 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is 3 years of age ± 90 days
- •Weight for length is within 10th to 90th percentile as plotted on WHO growth charts
- •Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis
- •Parent is willing to exclude sources of DHA from child's diet during the study
- •Parent agrees not to give vitamins to child during the study
- •English is the primary language in the home
- •Signed Informed Consent and Protected Health Information
排除标准
- •Gestational age at birth ≤ 36 weeks
- •History of neuro/psychiatric conditions
- •History of underlying metabolic or chronic disease
- •Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing
- •History of suspected or known cow milk protein intolerance
- •Child's diet contains sources of supplemental DHA more than one time per week
- •Child is from a multiple birth and the sibling(s) are living in the same household
- •Child is enrolled in another interventional clinical research study
- •Use of antihistamines within 12 hours of cognitive testing
结局指标
主要结局
Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid
时间窗: 6 months
Cognitive Measures - Executive Function, Language Development, and Behavior Assessment
时间窗: 6 months
次要结局
- Blood Pressure(6 months)
- Fatty Acid Desaturase (FADS) genotypes(Once)
- Plasma Vitamin D levels(6 months)
- Iron levels in the blood(6 months)
- Height and Weight(6 months)
- Recall of dietary intake at each study visit(6 months)
- Parental Product Assessment Questionnaire completed at Study Visit 2(once)
- Medically-confirmed adverse events collected throughout the study period(6 months)
- Heart Rate(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Effect of DHA Supplements on Macular Function in Patients With Stargardt Macular Dystrophy and Stargardt-like Macular DystrophyMacular DegenerationNCT00060749National Eye Institute (NEI)22
已完成
不适用
Study of Docosahexaenoic Acid (DHA) Supplementation in Patients With X-Linked Retinitis PigmentosaRetinitis PigmentosaNCT00004827Retina Foundation of the Southwest46
已完成
2 期
Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm LaborPregnant Women Diagnosed With Threatened Preterm LaborNCT06302023Khon Kaen University60
Unknown
4 期
Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn.Childhood ObesityNCT04151758University of Milan30
已完成
不适用
Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of PrematurityRetinopathy of PrematurityNCT02683317Coordinación de Investigación en Salud, Mexico110