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To Compare the safety and efficacy of Vitamin D, with Magnesium in mild to moderate Covid 19 patients

Randomized, Double Blind, Parallel Group Study of Vitamin D3 & Magnesium in Covid 19 Infection - Covid

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026189
Enrollment
210
Registered
2020-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Cholecalciferol vitamin D 3 Magnesium Glycinate : Vitamin D 60000 IU Single Dose + Magnesium Glycinate 250mg BD for 14 days

Sponsors

Suraksha Pharma Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, 20 to 60 years of age with mild â?? 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.) 2. Participants who are willing to provide inform consent and willing to come for schedule follow up visit. 3. Participants who are having normal hematological renal hepatic Parameters 4. Participant not having contra indication to take standard treatment Vitamin D, magnesium 5. Participants tested positive for COVID 19 by nose throat swab using PCR technique 6. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study.

Exclusion criteria

Exclusion criteria: 1. Patient having severe COVID -19 infection 2. Patients 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). 3. Participants with hypersensitivity or intolerance or contraindication to the use of standard treatment 4. Participants with known allergy or contraindication to Vitamin D, Magnesium 5. History of having received any investigational drug in the preceding one month. 6. History of taking any kind of formulation or any other form of therapy for COVID 19 prophylaxis . 7. Unwilling to come for regular follow-up for the entire duration of the study. 8. COVID -19 RT-PCR Negative 9. Any condition that, in the opinion of the investigator, does not justify the subjectâ??s inclusion in the study. 10. Participants participating in other clinical study. 11. Participant receiving other immune enhancers. 12. Refusal to sign informed consent form 13. Symptomatic for sever COVID-19 infection needing ICU 14. Atherosclerotic Coronary Artery Disease

Design outcomes

Primary

MeasureTime frame
Negative RT- PCR test for COVID 19 infection 2 Improvement in Signs and symptoms of COVID 19 infection, use of ventilator, length of stay in ICU 3 Reduction in CRP levels 4 Reduction in rate of COVID -19 complication . 5 Speed of recovery and duration to becoming asymptomatic 6 Length of hospital stay Timepoint: COVID 19 RT-PCR Test in 2 weeks

Secondary

MeasureTime frame
To compare the safety and efficacy of Vitamin D ( Cholecalciferol ) , with Magnesium in mild to moderate COVID- 19 patients Timepoint: 3 weeks

Countries

India

Contacts

Public ContactAVN Sridhar

suraksha pharma

svp@surakshapharma.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026