NCT00610922已完成不适用
RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,160
- 主要终点
- time of achieving the four gross motor development milestones
研究概览
简要总结
To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •weight at birth equal or above 2500 g;
- •gestational age between 37 and 42 completed weeks;
- •single birth;
- •absence of neonatal or birth abnormalities;
- •Apgar score greater than or equal to 7 at 5 m;
- •white parents.
排除标准
- •presence of neonatal diseases requiring hospitalisation for longer than 7 days;
- •unknown father;
- •parents unable to understand the protocol requirements and to fill out the infants diary;
- •infant already enrolled or selected for another clinical study.
研究组 & 干预措施
1
No Intervention
2
Experimental
干预措施: Docosahexaenoic acid (DHA) (Dietary Supplement)
结局指标
主要结局
time of achieving the four gross motor development milestones
时间窗: 4, 8 and 12 months of age
次要结局
- time of achieving early fine motor milestones and language(4, 8 and 12 months of age)
研究者
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