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Trial record 1 of 41 for:    vitamin D | COVID-19
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Vitamin D and COVID-19 Management

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ClinicalTrials.gov Identifier: NCT04385940
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Aldo Montano-Loza, University of Alberta

Tracking Information
First Submitted Date  ICMJE May 8, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date June 5, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
Symptoms recovery [ Time Frame: Time from onset of intervention to day 21 ]
Number of Participants whose symptoms recovered over three weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
  • Hospitalization [ Time Frame: Between diagnosis and day 21 ]
    Number of patients who required hospitalization
  • Blood white blood cell count (WBC) [ Time Frame: At day 0 before starting intervention and day 21 of intervention ]
    x 109/L
  • Duration of mechanical ventilation [ Time Frame: Between diagnosis and day 21 ]
    If patients required mechanical ventilation at any time after diagnosis
  • Duration of hospitalization [ Time Frame: Between diagnosis and day 21 ]
    Length of stay in hospital (days)
  • Intensive care unit (ICU) admission [ Time Frame: Between diagnosis and day 21 ]
    Number of patients who required ICU
  • Duration of ICU stay [ Time Frame: Between diagnosis and day 21 ]
    Length of stay in ICU
  • Blood C-reactive protein (CRP) [ Time Frame: Baseline and day 21 ]
    mg/L
  • Blood Lymphocyte count [ Time Frame: Baseline and day 21 ]
    number of lymphocytes in 1 microliter (µL) of blood
  • Blood Ferritin [ Time Frame: Baseline and day 21 ]
    ng/mL
  • Blood platelet count [ Time Frame: Baseline and day 21 ]
    platelets per microliter of blood
  • Blood interleukin-6 (IL-6) [ Time Frame: Baseline and day 21 ]
    pg/mL
  • Blood Tumor Necrosis Factor alpha (TNF) [ Time Frame: Baseline and day 21 ]
    pg/ml
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and COVID-19 Management
Official Title  ICMJE Improving Vitamin D Status in the Management of COVID-19
Brief Summary

A novel coronavirus disease 2019 (COVID-19) outbreak is a global dramatic pandemic that is immeasurably impacting the communities. Due to lack of data, symptomatic management is used for COVID-19 infection including oxygen therapy and mechanical ventilation for those with severe infection. Considering immunomodulatory, anti-inflammatory anti-fibrotic and anti-oxidant actions of vitamin D, it's safety and ease of administration, as well as direct effects of vitamin D on immune cell proliferation and activity, pulmonary ACE2 expression and reducing surface tension, evaluation of vitamin D supplementation as an adjuvant therapeutic intervention could be of substantial clinical and economic significance. High prevalence of vitamin D deficiency in elderly, smokers, patients with chronic diseases and excess uptake by adipose tissue in obesity make investigations of its role as a secondary therapeutic agent in COVID-19 conceivable. It should be necessary to monitor serum 25(OH)D levels in all inpatient and outpatient populations with COVID-19 to identify the importance of maintaining or promptly increasing circulating levels of 25(OH)D into the optimal range of 100-150 nmol/L.

The aim of this study is to conduct a double blind, randomized, controlled three weeks clinical trial on the efficacy of vitamin D (daily low dose versus weekly high dose) in COVID-19 patients in order to determine the relationship between baseline vitamin D deficiency and clinical characteristics and to asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery.

Subjects who are randomized to high-dose will be asked to take 50,000 IU for two times during the first week and one dose over second and third weeks to quickly raise their serum levels. Subjects in the low-dose arm will take vitamin D 1000 IU daily for three weeks.

Detailed Description

In-patients

  1. Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients.
  2. Determine the relationship between baseline vitamin D status and disease severity, laboratory biochemical tests of white blood cell count (WBC), C-reactive protein (CRP), lymphocyte count, leukocytes counts and neutrophil-lymphocyte-ratio (NLR), lactate dehydrogenase, IL-6, IL-1beta, TNF-alpha platelet count, albumin, and serum ferritin, required hospitalization and intensive care unit (ICU) admission.
  3. Asses patients' initial response to vitamin D supplementation in week one and determine its association with disease progression and recovery.
  4. Compare disease severity and progression, laboratory biochemical tests of white blood cell count (WBC), C-reactive protein (CRP), lymphocyte count, lactate dehydrogenase, IL-6, IL-1beta, TNF-alpha, platelet count, albumin, and serum ferritin, hospital admission and length of stay, duration of mechanical ventilation, hospital mortality and respiratory failure differ between the early responder and non-responder groups.

Out-patients

  1. Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients.
  2. Determine the relationship between baseline vitamin D deficiency and clinical characteristics.
  3. Asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Dietary Supplement: Ddrops® products, 50,000 IU, Oral
    Vitamin D3
  • Dietary Supplement: Vitamin D3
    Vitamin D3 1000IU
Study Arms  ICMJE
  • Experimental: High dose vitamin D
    Ddrops® products,Vitamin D3, 50,000 IU, Oral
    Intervention: Dietary Supplement: Ddrops® products, 50,000 IU, Oral
  • Active Comparator: Low dose vitamin D
    Vitamin D3 1000IU
    Intervention: Dietary Supplement: Vitamin D3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2020)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients with COVID-19:

  • ≥ 17 years old
  • Both sexes

Exclusion Criteria:

  • Patients with dementia, learning disability, mental health needs and alcohol or drug dependency, pregnant women will be excluded.
  • Patients with sarcoidosis, hypercalcemia, known vitamin D intolerance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04385940
Other Study ID Numbers  ICMJE 00100606
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Aldo Montano-Loza, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alberta
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP