CTRI/2020/06/026189.

Study name	Randomized, double blind, parallel group study of vitamin D3 & magnesium in Covid 19 infection
Methods	Trial design: RCT Sample size: 210 Setting: inpatient Language: English (India) Number of centres: 1 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Patients of either sex, 20 to 60 years of age with mild – moderate COVID ‐19 infection, found positive for COVID ‐19 test by RT_PCR are requiring clinical management symptomatic patients who present with cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, insomnia, ageusia or alternative signs of respiratory infections.) Participants who are willing to provide inform consent and willing to come for schedule follow‐up visit. Participants who are having normal hematological renal hepatic parameters Participants not having contra indication to take standard treatmentvitamin D, magnesium Participants tested positive for COVID 19 by nose throat swab using PCR technique Signed informed consent, demonstrating that the participant understands the procedures required for the study and the purpose of the study. Exclusion criteria Participants having severe COVID ‐19 infection Participants presenting severe respiratory and/or multi systemic symptoms compatible with advanced COVID‐19 and inter current acute or severe chronic diseases (i.e. active cancer). Participants with hypersensitivity or intolerance or contraindication to the use of standard treatment Participants with known allergy or contraindication to Vitamin D, magnesium History of having received any investigational drug in the preceding one month. History of taking any kind of formulation or any other form of therapy for COVID 19 prophylaxis . Unwilling to come for regular follow‐up for the entire duration of the study. COVID ‐19 RT‐PCR negative Any condition that, in the opinion of the investigator, does not justify the participant‘s inclusion in the study. Participants participating in other clinical study. Participant receiving other immune enhancers. Refusal to sign informed consent form Symptomatic for sever COVID‐19 infection needing ICU Atherosclerotic coronary artery disease
Interventions	Details of intervention Dose: vitamin D 400,000 IU single dose + magnesium glycinate 250 mg twice daily Route of administration: for 14 days Treatment details of control group (e.g. dose, route of administration): Dose: vitamin D 60,000 IU single dose + magnesium glycinate 250 mg twice daily Route of administration: for 14 days Concomitant therapy: standard COVID‐19 treatment
Outcomes	Primary study outcome Negative RT‐ PCR test for COVID 19 infection Improvement in signs and symptoms of COVID 19 infection, use of ventilator, length of stay in ICU Reduction in CRP levels Reduction in rate of COVID ‐19 complication . Speed of recovery and duration to becoming asymptomatic Length of hospital stay Review outcomes All‐cause mortality at day 28, day 60, time‐to‐event, and at hospital discharge ‐ NP Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale (WHO 2020e), WHO Ordinal Scale for Clinical Improvement (WHO 2020f)) at day 28, day 60, and up to longest follow‐up); including: Improvement of clinical status: weaning or liberation from invasive mechanical ventilation in surviving patients i.e. WHO ≤ 6, if ≥7 at baseline; ventilator‐free days; ventilator free defined as WHO ≤ 6; duration to liberation from invasive mechanical ventilation; liberation from supplemental oxygen in surviving patients i.e. WHO ≤ 4, if ≥5 at baseline; duration to liberation from supplemental oxygen Worsening of clinical status: need for invasive mechanical ventilation i.e. WHO 7‐9, if ≤ 6 at baseline; need for non‐invasive mechanical ventilation or high flow i.e. WHO = 6, if ≤5 at baseline; need for oxygen by mask or nasal prongs i.e. WHO = 5, if ≤4 at baseline NP Need for dialysis (at up to 28 days) ‐ not planned Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) at up to 7 days; up to 30 days, and longest follow‐up available ‐ NP Admission to ICU ‐ probably reported Duration of hospitalisation ‐ reported Time to discharge from hospital ‐ probably reported Viral clearance, assessed with reverse transcription polymerase chain reaction (RT‐PCR) test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days ‐ reported Vitamin D serum levels ‐ NP Serious adverse events, defined as number of participants with event ‐ probably reported Adverse events (any grade, grade 1‐2, grade 3‐4), defined as number of participants with event ‐ probably reported Additional study outcomes: safety and efficacy
Starting date	01/08/2020
Contact information	AVN Sridhar suraksha pharma 8‐3‐898/5, suraksha towers, Ameerpet, Hyderabad TELANGANA 500073 India svp@surakshapharma.com
Notes	Recruitment status: not yet recruiting Prospective completion date: 01.02.2022 Date last update was posted: NR Sponsor/funding: suraksha pharma