Effect of Parenteral and Enteral Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Serum Selenium
研究概览
简要总结
The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium supplemented parenteral nutrition from initiation of parenteral nutrition until discontinuation of preterm formula or hospital discharge.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight less than 1500 g at birth
- •Not capable of receiving enteral feedings prior to 7 days postnatally
排除标准
- •Metabolic abnormalities such as inborn errors of metabolism
- •Current viral infections
- •Enterocolitis confirmed by diagnosis
- •Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
- •Evidence of chronic white blood cell disease
研究组 & 干预措施
PN without selenium and formula sodium selenate
Parenteral nutrition (PN) without selenium and sodium selenate supplementation of infant formula
干预措施: Without selenium and sodium selenate supplementation (Other)
PN without selenium and formula sodium selenite
Parenteral nutrition (PN) without selenium and sodium selenite supplementation of infant formula
干预措施: Without selenium and sodium selenite supplementation (Other)
PN selenium and formula sodium selenate
Parenteral nutrition (PN) with selenium and sodium selenate supplementation of infant formula
干预措施: selenium and sodium selenate supplementation (Other)
PN selenium and formula sodium selenite
Parenteral nutrition (PN) with selenium and sodium selenite supplementation of infant formula
干预措施: selenium and sodium selenite supplementation (Other)
结局指标
主要结局
Serum Selenium
时间窗: Change from Baseline to Discharge (~50-60 days)
4 timepoints include 1) baseline prior to initiation of parenteral nutrition; 2) initiation of enteral nutrition; 3) at discontinuation of parenteral nutrition; 4) at discontinuation of preterm formula/discharge
次要结局
- Weight(Change from study day 1 to study exit (~50-60 days))
- Length(Change from study day 1 to study exit (~50-60 days))
- Head Circumference(Change from study day 1 to study exit (~50-60 days))
- Intake(Change from study day 1 to study exit (~50-60 days))
- Serum Copper(Change from Baseline to Discharge (~50-60 days))
- Serum Zinc(Change from Baseline to Discharge (~50-60 days))
- WBC Super oxide dismutase (SOD) activity(Change from Baseline to Discharge (~50-60 days))
- Glutathione peroxidase (GSHpx) activity(Change from Baseline to Discharge (~50-60 days))
- Plasma GSHpx activity(Change from Baseline to Discharge (~50-60 days))
- Plasma Amino Acid Concentrations(Change from Baseline to Discharge (~50-60 days))