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To Study the Role of Vitamin D in the Treatment of Confirmed COVID-19 Infection

To Study the Role of Vitamin D in the Treatment of Confirmed COVID-19 Infections

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030083
Enrollment
100
Registered
2020-12-29
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 Health Condition 2: O- Medical and Surgical Health Condition 3: B338- Other specified viral diseases

Interventions

Intervention1: DEKSEL Nano Syrup: 1. Uncomplicated illness-3,60,000-6,00,000IU 6-10days Once a day 2. Mild Pneumonia- 3,60,000-6,00,000IU 6-10days Once a day 3. Severe Pneumonia- 3,60,000-6,00,000IU 3

Sponsors

Pulse Pharmaceuticals Pvt Ltd
Lead Sponsor
Pulse Pharmaceuticals Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged above 18 years either gender with positive RT-PCR for novel Corona Virus causing Covid-19 pandemic. 2.Only patients categorized as suffering from uncomplicated illness (category 1), mild pneumonia (category 2) and severe pneumonia (category 3) as defined by ICMR dt. 31-03-2020, will be selected to participate in the study. 3.Women of childbearing potential must agree to use contraception for the duration of the study. 4.Patients or their legally acceptable representative willing to sign the informed Consent form.

Exclusion criteria

Exclusion criteria: 1. Patients less than 18 years of age. 2. Patience who have taken high dose vitamin D (i.e.60,000 IU of Vitamin D) In the last 3months either daily, Weekly or monthly or whose 25 (OH) D level is above 30 ng/ml. 3. Refusal to participate expressed by patient or legally authorised representative if they are present. Refusal to sign the informed Consent form. 4. Patients of category 4, 5, 6 ( ARDS, Sepsis, Septic Shock) Respectively as a defined by ICMR. 5. Patients suffering from active malignancy. 6. Severe chronic kidney disease or requiring dialysis ( i.e. eGFR 7. Pregnancy and breast-feeding. 8. Anticipated transfer to another hospital which is not a study site within 72 hours. 9. Contraindication to any study medication including allergy. 10. Human immunodeficiency virus infection under highly active antiretroviral therapy ( HAART).

Design outcomes

Primary

MeasureTime frame
1. Difference in two study groups with respect to the duration and severity of signs and symptoms. 2. Time taken for Double negative RT-PCR between the two study groups 3. Duration of hospital stay. 4. Difference in the blood parameters and comparable symptoms between the two groups after the intervention.Timepoint: 24 weeks

Secondary

MeasureTime frame
1. Intensive care unit admission. 2. Recovery 3. Composite of cumulative death, i.e., all causes and specific causes mortality.Timepoint: 24 weeks

Countries

India

Contacts

Public ContactDr Shyam Sundar Varaprasad Raju

Gandhi Medical College & Gandhi Hospital

drgsgmbbs@gmail.com9848152349

Outcome results

None listed

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