Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum interleukin-6
研究概览
简要总结
This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.
详细描述
Vitamin D has an important role in the regulation of both the innate and adaptive immune systems. There are very few studies of such roles in the neonatal population. It is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. There is no consensus regarding to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The influence of different doses of vitamin D on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. This RCT will evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis we will also evaluate their safety and influence on clinical outcomes of these infants
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm Infants (28-37 wk gestational age)
- •Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:
- •Temperature instability (hypothermia, hyperthermia);
- •Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
- •Neurologic (hypotonia, lethargy, seizures);
- •Gastrointestinal (feeding intolerance, abdominal distension).
排除标准
- •Major congenital anomalies.
- •Chromosomal anomalies.
- •Known inborn error(s) of metabolism
研究组 & 干预措施
High-dose vitamin D
Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU
干预措施: High-dose vitamin D 3 (Drug)
Conventional-dose vitamin D
Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU
干预措施: Conventional-Dose Vitamin D 3 (Drug)
结局指标
主要结局
Serum interleukin-6
时间窗: At trial entry and 7 days after daily vitamin D supplementation therapy
Serum levels of interleukin-6 (IL-6) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy. IL-6 concentrations will be determined by Endogenous Interleukin-ELISA
Serum tumor necrosis-alpha
时间窗: At trial entry and 7 days after daily vitamin D supplementation therapy
Serum levels of tumor necrosis-alpha (TNF-alpha) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy
次要结局
- Serum C-reactive protein (CRP)(At trial entery and 7 days after daily vitamin D supplementation therapy)
- Serum 25(OH)D levels(at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age)
- Serum calcium, phosphorus and urinary calcium(Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks)
- Neonatal morbidities(Participants will be followed for the duration of hospital stay, for an expected average of 4 weeks)
- Abdominal ultrasonography(40 weeks postmenstrual age)
- Mortality(Baseline)
研究者
Hesham Abdel-Hady
Professor of Pediatrics
Mansoura University Children Hospital