Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency.
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|ClinicalTrials.gov Identifier: NCT02868827|
Recruitment Status : Terminated (The initial plan was 2 years but due to slow recruitment. We were able to screen 635 patients in 4 years and recruited only 127 patients.)
First Posted : August 16, 2016
Last Update Posted : June 18, 2020
The purpose of the research study is to determine whether a single high dose of vitamin D is helpful in reducing critical illness related complications in intensive care patients who are having sever vitamin D deficiency.
Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A number of scientific studies have documented a strong correlation between low levels of vit.D and increased rate of adverse outcomes including infection, acute kidney injury and mortality in ICU patients. A recent randomized controlled trial (RCT) has demonstrated a 50% reduction in hospital mortality in severe vit.D deficient patients following a single high dose of cholecalciferol (Vitamin D3). However, the role of Vit.D supplementation to boost up host immune system and eventually reduction of mortality has yet to be determined by large randomized controlled trials in humans. Hence the study aims to run a randomized controlled trial (RCT) in order to study the role of Vitamin D in critically ill patients.
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Critical Illness||Drug: Cholecalciferol Other: Milk (Nestle)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency in Intensive Care Unit- A Randomized Controlled Trial.|
|Actual Study Start Date :||August 27, 2017|
|Actual Primary Completion Date :||November 9, 2019|
|Actual Study Completion Date :||November 9, 2019|
This group of patients will receive single high dose of vitamin D (Cholecalciferol) dissolved in 45 ml of fresh milk (Nestle)
400000 international Units of cholecalciferol will be dissolved in 45 ml of fresh milk (Nestle) and it will be given to interventional group patients through enteral route within 24 hours of ICU admission as a single dose.
Other Name: Vitamin D3
Placebo Comparator: Placebo
This group of patients will receive placebo - 45 ml of fresh milk (Nestle) so that the amount, color, smell, taste etc will be the same as that of experimental drug)
Other: Milk (Nestle)
45 ml of Nestle milk will given to patients assigned as placebo
- Reduction in hospital mortality [ Time Frame: 28 days ]as assessed by hospital mortality rate
- Emergence of Multidrug resistant (MDR) organisms [ Time Frame: 28 days ]as evidenced by microbiological culture and sensitivity reports from samples taken from patients blood, sputum,urine and body fluids.
- Vasopressor requirement [ Time Frame: 28 days ]as evidenced by invasive blood pressure monitoring during ICU stay.
- Ventilator free days [ Time Frame: 28 days ]How long is the free days
- ICU length of stay [ Time Frame: 28 days ]How long the patient will stay in ICU
- Hospital length of stay [ Time Frame: 28 days ]How long the patient will stay in Hospital
- New onset of Acute kindney injury [ Time Frame: 28 days ]It will be assessed by rising serum creatinine level and decreasing urine out put per hour.
- Development of acute CVA [ Time Frame: 28 days ]as evidenced by neurological deficit and CT sacn/MRI findings
- Upper and lower GI bleeding [ Time Frame: 28 days ]It will be assessed by decreasing hemoglobin levels and endoscopic findings.
- Acute co-morbidities [ Time Frame: 28 days ]including, acute kidney injury, Myocardial Infarction, Cerebrovascular accidents, upper or lower gastro intestinal bleed)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868827
|King Abdullah Medical City, Holy Capital|
|Mecca, Makkah Western, Saudi Arabia, 21955|
|Study Chair:||Asiah S Rugaan, MD, MRCP||King Abdullah Medical City Makkah|