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Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Asiah Rugaan, King Abdullah Medical City

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cholecalciferol
This group of patients will receive single high dose of vitamin D (Cholecalciferol) dissolved in 45 ml of fresh milk (Nestle)
Drug: Cholecalciferol
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




Primary Outcome Measures :
  1. Reduction in hospital mortality [ Time Frame: 28 days ]
    as assessed by hospital mortality rate


Secondary Outcome Measures :
  1. 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.

  2. Vasopressor requirement [ Time Frame: 28 days ]
    as evidenced by invasive blood pressure monitoring during ICU stay.

  3. Ventilator free days [ Time Frame: 28 days ]
    How long is the free days

  4. ICU length of stay [ Time Frame: 28 days ]
    How long the patient will stay in ICU

  5. Hospital length of stay [ Time Frame: 28 days ]
    How long the patient will stay in Hospital

  6. 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.

  7. Development of acute CVA [ Time Frame: 28 days ]
    as evidenced by neurological deficit and CT sacn/MRI findings

  8. Upper and lower GI bleeding [ Time Frame: 28 days ]
    It will be assessed by decreasing hemoglobin levels and endoscopic findings.

  9. Acute co-morbidities [ Time Frame: 28 days ]
    including, acute kidney injury, Myocardial Infarction, Cerebrovascular accidents, upper or lower gastro intestinal bleed)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years or older.
  2. Both male and female
  3. Within 24 hours from admission.
  4. Having 25 -Hydroxyvitamin D level of 12 ng/ml or lower.

Exclusion Criteria

  1. Pregnant or lactating females.
  2. Do not resuscitate (DNR) status or comfort measures only
  3. No consent
  4. Severely impaired gastrointestinal functions (e.g, paralytic ileus, continuous nasogastric tube drainage, strict nil per oral- no medication, malabsorption syndrome, chronic diarrhea etc)
  5. History of renal stones within past year
  6. Past history of hypercalcemia, tuberculosis or sarcoidosis.
  7. Baseline serum total calcium ≥10.6 mg/dl or ionized serum calcium ≥ 5.4 mg/dl.

Information from the National Library of Medicine

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


Locations
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Saudi Arabia
King Abdullah Medical City, Holy Capital
Mecca, Makkah Western, Saudi Arabia, 21955
Sponsors and Collaborators
King Abdullah Medical City
Investigators
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Study Chair: Asiah S Rugaan, MD, MRCP King Abdullah Medical City Makkah
Publications:

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Responsible Party: Asiah Rugaan, Consultant and Head of Department - Intensive Care Unit, King Abdullah Medical City
ClinicalTrials.gov Identifier: NCT02868827    
Other Study ID Numbers: 16-252
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asiah Rugaan, King Abdullah Medical City:
cholecalciferol and critical illness
Mortality and cholecalciferol supplementation
Additional relevant MeSH terms:
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Vitamin D Deficiency
Critical Illness
Disease Attributes
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents