The Effect of Vitamin D Supplementation on COVID-19 Recovery
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The COVID-19 caused by SARS-CoV-2 has transmitted quickly as a global public health
      emergency. The median duration for Sars-CoV-2 carrying in COVID-19 patients was 20 days (IQR
      16-28) What is the role of vitamin D supplementation on the recovery time of asymptomatic and
      pauci-symptomatic COVID-19 subjects? the intervention group will have vitamin D
      supplementation (200,000 IU / 1 ml of Cholecalciferol (1 ml) Oral form). Control group will
      have a placebo treatment (physiological saline).

      the negative RT-PCR date will be compared in the two groups
    

Detailed description: 
      Introduction In 2020 The world is incurring coronavirus pandemic. The epidemic of the new
      coronavirus started in Wuhan, China, in late 2019, originally called 2019-nCoV and then
      COVID-19 by the World Health Organization in February 2020.

      COVID-19 presented a heavy health systems burden having caused more than 170,000 deaths
      worldwide as of April 20, 2020. However, the treatment protocols for this infection remain
      controversial. It is the subject of several ongoing studies.

      The use of vitamin D as a strategy to reduce the frequency and severity of respiratory
      infections and in particular COVID-19 must be seriously considered.

      Several studies have studied the role of vitamin D in reducing the risk of viral infections.
      Indeed, vitamin D supplementation could be a useful measure in improving the immune response
      of subjects affected by the new coronavirus. This, taking into account the high prevalence of
      vitamin D deficiency in our country.

      The beneficial effects of vitamin D on protective immunity is partly due to innate immune
      system action. It reduces the cytokine storm induced by the innate immune system, by
      decreasing the expression of pro-inflammatory cytokines and increasing that of
      anti-inflammatory cytokines. Vitamin D played a major role in the modulation of adaptive
      immunity. However, evidence on the effectiveness of vitamin D in improving the immune
      response of confirmed COVID-19 remains lacking.

      The prolonged duration of the disease may increase the likelihood of transmission. Indeed,
      the R0 depends on three factors including the contact rate between individuals in the
      population, the probability of transmission of the infection during contact and the duration
      of infectiousness. The COVID-19 caused by SARS-CoV-2 has transmitted quickly as a global
      public health emergency. The median duration for Sars-CoV-2 carrying in COVID-19 patients was
      20 days (IQR 16-28)(9).

        1. Research question:

           What is the role of vitamin D supplementation on the recovery time of asymptomatic and
           pauci-symptomatic COVID-19 subjects?

        2. Objectives of the study:

           To assess the effect of vitamin D supplementation on the duration of carriage of the
           COVID-19 virus in patients with SARS Cov2 with a positive control RT-PCR on day 14 of
           the date of confirmation of the disease.

        3. Type of study:

      This is a randomized clinical trial without the patient's knowledge in subjects diagnosed
      with COVID-19.

      B. Method:

        1. Study setting: this study will be carried out in the governorate of Monastir in the
           collective isolation center

        2. Eligibility criteria: patients with SARS Cov2 and having a positive RT-PCR at control in

             -  14 days from confirmation of infection for asymptomatic subjects and

             -  7 days after the disappearance of symptoms for pauci-symptomatic subjects.
                Non-inclusion criteria: Pregnant women and children under the age of 18 will not be
                included.

        3. Intervention: the intervention group will have vitamin D supplementation (200,000 IU / 1
           mL of Cholecalciferol (1 ml) Oral form). Control group will have a placebo treatment
           (physiological saline).

        4. Output: the negative RT-PCR date will be compared in the two groups.

        5. Variables: we will study the socio-demographic characteristics (age, sex, level of
           study) and the recovery dates (dates of confirmation samples, disappearance of symptoms
           and control) the presence of hospitalization.

        6. Sample size: for a gain of 07 days for healing, with 90% power and a 2-sided 0.05
           significance level, 130 patients were required (65 in each group).

      C. Allocation of interventions:

      After a phone agreement, a doctor ensures the treatment distribution. D. Ethical
      considerations This survey will be carried out respecting the research ethical
      considerations: consent (free, informed, written, clear and loyal) anonymity;
      confidentiality; protection and assistance.

      E. Study budget The Monastir University Hospital of Monastir will fund study (buying Vit D).
      F. Study schedule This interventional investigation will begin in July 2020. Patient
      monitoring will be carried out until the recovery date. (2 negative RT-PCR tests).
    

Intervention name(s): Vit-D 0.2 MG/ML Oral Solution [Calcidol]; Physiological Irrigating Solution
Intervention type(s): Drug; Drug
Intervention description(s): ARM 1 : Cholecalciferol 200,000 IU / 1 mL .; ARM 2 : placebo
Intervention MeSH terms: Pharmaceutical Solutions; Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized clinical trial with 2 parallel arms and participant masking
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COVID 19; Vitamin D; Recovery