The Efficacy of Enteral Vitamin D Supplementation at a Dose of 800 IU Compared to 400 IU in Preterm Infants With a Gestational Age of 28-34 Weeks Admitted to the Neonatal Care Unit
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- 25(OH)D level
研究概览
简要总结
The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks. The main questions it aims to answer is:
- Does higher dose of enteral vitamin D supplementation (800IU/day) increase vitamin D level better than standard recommended dose (400IU/day) to achieve sufficient level of vitamin D?
Participants will:
- Take the enteral vitamin D supplementation every fay for 28 days
- Have their blood level of vitamin D examined before and after supplementation for 28 days
详细描述
The study conducted in 2 hospitals in Jakarta region, RSCM and RSUD Koja. Preterm with 28 to 34 weeks of gestational age and fulfill the inclusion criteria will be enrolled in the study after parents signed the informed consent.
Blood sample will be collected to get the baseline of vitamin D serum. The study subject will be given enteral vitamin D supplementation for 28 days (4 weeks). The dosage of vitamin D is randomized with block randomized in sealed envelope.
Subjects then will be followed up to 28 days of supplementation. After 28 days of supplementation, the subjects' blood will be collected to get the vitamin D serum level. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •neonates with gestational age 28-34 weeks
- •tolerated enteral feedings more than 30ml/kg
排除标准
- •infants with major congenital anomaly
- •infants with gastrointestinal obstruction
- •infants with congenital renal failure
- •infants with cholestassis
研究组 & 干预措施
400 IU
Participants will receive enteral vitamin D supplementation of 400 IU/day for 28 days
干预措施: Enteral vitamin D supplementation of 400 IU/day (Dietary Supplement)
800 IU
Participants will receive enteral vitamin D supplementation of 800 IU/day for 28 days
干预措施: Enteral vitamin D supplementation of 800 IU/day (Dietary Supplement)
结局指标
主要结局
25(OH)D level
时间窗: From enrollment to the end of treatment at 4 weeks
serum level of 25(OH)D
次要结局
未报告次要终点
研究者
Rosalina Dewi Roeslani
Head of Neonatology Division, Principal Investigator
Indonesia University