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Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease

NCT ID: NCT04952857

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2021-12-10

Brief Summary

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COVID-19 caused by SARS-CoV-2 virus has affected the lives of millions of individuals globally and also severely strained the medical community. Pre-symptomatic and asymptomatic SARS-CoV-2 positive individuals far outnumber the symptomatic ones or those with severe disease. The transmission potential of SARS CoV-2 is potentially greater than earlier viral outbreaks of SARS-CoV and MERS-CoV.Routine measures of social distancing, personal hand hygiene and limited outdoor contact activities have shown benefits to limit corona virus infection. However, the role of vitamin D in SARS-CoV-2 infection is sparingly explored despite the knowledge of an immunomodulatory role and protective effect of vitamin D against viral infections. Meta-analysis of five clinical trials of vitamin D supplementation found that those receiving vitamin D supplementation had fewer respiratory tract infections (odds ratio = 0.58 (95%CI, 0.42 - 0.81).Any immune-modulatory effect of vitamin D is likely to be observed at levels which are considered higher than that required for normal bone metabolism.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention

Vitamn D 6 lakh IU oral stat

Group Type EXPERIMENTAL

cholecalciferol 6 lakh IU

Intervention Type DRUG

vitamin D levels and serum calcium will be assessed at day 3,7, 14.

Placebo

Placebo equal volume/ weight

Group Type PLACEBO_COMPARATOR

cholecalciferol 6 lakh IU

Intervention Type DRUG

vitamin D levels and serum calcium will be assessed at day 3,7, 14.

Interventions

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cholecalciferol 6 lakh IU

vitamin D levels and serum calcium will be assessed at day 3,7, 14.

Intervention Type DRUG

Other Intervention Names

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vitamin D

Eligibility Criteria

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Inclusion Criteria

1. RT-PCR proven SARS-CoV-2 infection or computed tomography scan findings compatible with the COVID19 disease (bilateral multifocal ground-glass opacities ≥50%)
2. Moderate to severe COVID-19 defined by PFR ratio of \<200
3. SOFA score\>4
4. Patients with vitamin D deficiency defined as 25 (OH)D level\<20 ng/ml
5. Age\>18 years

Exclusion Criteria

* 1\. Vitamin D sufficient or already receiving vitamin D supplements 2. Active malignancy 3. Hypercalcemia, hyperparathyroidism 4. Chronic kidney disease (eGFR\<30 ml/min) 5. Pregnant and lactating women 6. Patient on mechanical ventilation at ICU admission
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Ashu Rastogi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Deptt of Endocrinology

Chandigarh, , India

Site Status

Countries

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India

References

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Singh A, Rastogi A, Puri GD, Ganesh V, Naik NB, Kajal K, Kahlon S, Soni SL, Kaloria N, Saini K, Hazarika A, Mahajan V, Singla K, Bhadada S, Soni V. Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S). J Public Health (Oxf). 2024 May 29;46(2):256-266. doi: 10.1093/pubmed/fdae007.

Reference Type DERIVED
PMID: 38291897 (View on PubMed)

Other Identifiers

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INT/2020/001068

Identifier Type: -

Identifier Source: org_study_id