Status:
COMPLETED
Vitamin D Supplementation in Intensive Care Unit Patients
Lead Sponsor:
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Collaborating Sponsors:
Faculty of Medicine of Tunis
Rabta University Hospital
Conditions:
Dietary Supplements
Intensive Care Unit
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
A randomized controlled trial is designed to investigate the safety and clinical efficacy of a mega dose of VD in patients admitted in intensive care unit (ICU). Patients will be randomly allocated to...
Detailed Description
The randomized controlled trial aimed to investigate the safety and clinical efficacy of a single mega dose of vitamin D (VD) in patients admitted at intensive care unit (ICU). Study participants: VD...
Eligibility Criteria
Inclusion
- newly admitted (within 24 hours)
- over eighteen,
- able to receive medication orally or through nasogastric tube
- expected to stay more than 72 hours in ICU
- given consent
Exclusion
- lack of patient's or relatives' consent
- expected short life or ICU stay (\<48 hours)
- sepsis at admission
- kidney, liver or intestinal disease
- hypercalcemia (total calcium\>10.6 mg/dL)
- history of a disorder associated with hypercalcemia (i.e., cancer, tuberculosis, sarcoidosis, hyperparathyroidism, nephrolithiasis)
- treatment with immunotherapy or vitamin supplements within one year
- pregnant or breastfeeding women
- discharge from ICU or death within 72 hours of admission
Key Trial Info
Start Date :
January 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT04915963
Start Date
January 20 2016
End Date
May 30 2019
Last Update
June 18 2021
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