The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Discharge
研究概览
简要总结
Vitamin D deficiency is highly prevalent in critically ill adult and pediatric population that causes multiple adverse health outcomes including higher illness severity score, increased morbidity and mortality, multiple organ dysfunction, longer duration of Mechanical ventilation, longer duration of Oxygen therapy and increased length of stay (LOS) in PICU and hospital. Vitamin D deficiency is a modifiable risk factor that can be corrected with high dose of vitamin D supplementation to improve the clinical outcome.
This study is designed to determine whether random vitamin D supplementation within dose limits improves clinical outcomes in critically ill children.
详细描述
Vitamin D is known for its role in bone metabolism and calcium haemostasis but it is also required for the optimal functioning of cardiovascular and innate immune systems.
As a pleiotropic hormone it has been increasingly implicated in proper functioning of multiple organs; its deficiency is associated with cardiovascular diseases, asthma, cancer, multiple sclerosis, diabetes and acute lower respiratory tract infections. Over one billion people are vitamin D deficient worldwide and in Pakistani population vitamin D deficiency is reported as high as 76% despite abundant sunshine.
Beside of ambulatory individuals, the patients presenting in intensive care units are also found Vitamin D deficient. In adult intensive care settings studies have shown vitamin D deficiency (VDD) present in 60% of critically ill adult patients.VDD is also very common in pediatric intensive care units (PICU) worldwide, ranging from 30 to 80%.
Although there is high prevalence of VDD in pediatric and adult population, but there is no uniform definition of VDD exists. Levels of active metabolite 1,25(OH)2D of Vitamin D at tissue level cannot be measured, however, patient's blood level of 25-hydroxy vitamin D is used to know vitamin D stores in the body. Patient with serum vitamin D level<20ng/ml is considered to be vitamin D deficient.
VDD is associated with clinically poor outcomes like increased duration of mechanical ventilation, increased length of hospital stay, Sepsis, Acute respiratory failure and mortality in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of age 6 months to 10 years, either gender admitted in ICU for critical illness (on medical record) with PIM-2 score suggesting probability of mortality more than 50%.
排除标准
- •Children with known adrenal, pituitary, hypothalamic or thyroid disease.
- •Those who have complex congenital defects.
- •Moribund at time of admission.
- •Those who were expected to be care withdrawn.
- •Patients who had received large dose regimen (200,000 IU or more) of vitamin D during the previous three months before admission.
研究组 & 干预措施
Vitamin D group
Consisted of 48 patients selected on admission via lottery method those will be given Vitamin D mega dose
干预措施: Vitamin D (Drug)
Normal Saline group
Consisted of 48 patients selected on admission via lottery method those will be given Normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Discharge
时间窗: upto one month
Patient became vitally stable and shifted out of PICU
Death
时间窗: upto one month
Patient is declared dead by duty doctor
次要结局
- Duration of O2 therapy(upto one month)
- Duration of Mechanical ventilation(upto one month)
- Duration of PICU stay(upto one month)
- Duration of Hospital stay.(upto one month)
研究者
Dr Mustahsin Khalil
Post graduate Trainee
King Edward Medical University