Multi-dose Vitamin D Supplementation in Preterm Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.
研究概览
简要总结
Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.
详细描述
Vitamin D is a fat-soluble vitamin that is either taken by dietary sources or synthesized upon exposure to sun light. Although major function is on bone metabolism, in recent years other effects of Vitamin D attracted attention. Low neonatal vitamin D levels were reported to be associated with increased risk of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and sepsis.
Vitamin D level in the fetus and the newborn is mostly dependent on maternal vitamin D levels. Most of the vitamin D is transferred to the fetus during third trimester and as a result preterm newborns especially those with <32 weeks gestational age are born with lower vitamin D stores. But there is no consensus regarding the adequate dose of vitamin D supplementation for preterm infants. The American Academy of Pediatrics recommends supplementation of 200-400 IU/d vitamin D for preterm infants. And the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends 800-1000 IU/d vitamin D supplementation for preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks
排除标准
- •perinatal asphyxia,
- •major congenital or chromosomal anomalies,
- •those with no expectation of survival in first 2 weeks
- •those that total parenteral nutrition was not ceased by the first 2 weeks
研究组 & 干预措施
Devit-3 Oral Drop 400 IU
supplemented with oral Vitamin D 400 IU/day (Devit-3 Oral Drop, 50000 IU/15 ml, Deva Company, Turkey) started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age
干预措施: Devit-3 Oral Drop (Drug)
Devit-3 Oral Drop 800 IU
Devit-3 Oral Drop 800 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age
干预措施: Devit-3 Oral Drop (Drug)
Devit-3 Oral Drop 1000 IU
Devit-3 Oral Drop1000 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age
干预措施: Devit-3 Oral Drop (Drug)
结局指标
主要结局
Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.
时间窗: 36 weeks
Serum concentration of 25(OH) D at 36 weeks postmenstrual age.
时间窗: 36 weeks
次要结局
未报告次要终点
研究者
Ozlem Bozkurt, MD
Neonatology fellow
Zekai Tahir Burak Women's Health Research and Education Hospital