The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.

      The existing evidences suggest that Vitamin D3 supplementation enhances recovery from
      influenza, recurrent pneumonias and tuberculosis. Recently, an observational study of adult
      patients suggested that patients with VDD showed decrease in the odds of all cause-mortality
      when their Vitamin D status was improved before hospitalization.

      A randomized study demonstrated that one time bolus dose of oral vitamin D supplementation
      caused decrease in mortality in a group of patients with severe VDD.

      A significant literature is available that suggests vitamin D deficiency as a modifiable risk
      factor in PICU settings. The recognized importance of vitamin D to the health of multiple
      organ systems suggest that rapid normalization could represent a simple, inexpensive, and
      safe means of improving outcomes and reducing health care spending.

      This study is designed to supplement large dose of vitamin D that may lead to fast correction
      of low vitamin D level in critically ill children and possibility of better clinical outcome.
      If such an association is established by this study, routine detection and use of Vitamin D
      might be recommended for critically ill children admitted to PICU.
    

Intervention name(s): Vitamin D; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D will be given to group A selected by Lottery method; Vitamin D will be given to group B slected by Lottery method
Other intervention name(s): vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: vitamin D; Supplimentation; Critically ill children