A Phase 4 interventional study of Vitamin D and Normal saline in Critically Ill, sponsored by Dr Mustahsin Khalil. Completed at 1 site in Pakistan. Open to participants aged 6 Months to 10 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Dr Mustahsin Khalil · Phase 4, Interventional, and Health services research
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 96 is close to the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →This is the only study on the registry with Dr Mustahsin Khalil as lead sponsor.
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Exclusion Criteria:
Consisted of 48 patients selected on admission via lottery method those will be given Vitamin D mega dose
Drug: Vitamin D
Consisted of 48 patients selected on admission via lottery method those will be given Normal saline
Drug: Normal saline
Vitamin D will be given to group A selected by Lottery method
Also known as: vitamin D3
Vitamin D will be given to group B slected by Lottery method
Death
Patient is declared dead by duty doctor
Time frame: upto one month
Discharge
Patient became vitally stable and shifted out of PICU
Time frame: upto one month
Duration of O2 therapy
Total time that patient required O2
Time frame: upto one month
Duration of Mechanical ventilation
Total time of Mechanical ventilation required by the patient
Time frame: upto one month
Duration of PICU stay
Total Duration of stay in PICU
Time frame: upto one month
Duration of Hospital stay.
Total duration of Hospital stay in wards except PICU stay
Time frame: upto one month
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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