Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04459247 |
| Other study ID # |
121/20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2020 |
| Est. completion date |
April 10, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Postgraduate Institute of Medical Education and Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Coronavirus-2019 (COVID-19) caused by severe acute respiratory syndrome-associated
coronavirus-2 (SARS-CoV-2) has affected the lives of millions of individuals globally and
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 greator than earlier viral outbreaks of SARS-CoV and
MERS-CoV. Identification of asymptomatic carriers of SARS-CoV-2 infection is paramount to
contain viral infection because of high transmission potential 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
not explored despite the knowledge of an immunomodulatory role and protective effect of
vitamin D against viral infections. It has been found that mortality from COVID-19 is more in
countries with vitamin D deficiency.
The role of therapeutic vitamin D supplementation in asymptomatic individuals with vitamin-D
deficiency and COVID-19 is not known. Immune-modulatory effect of vitamin D is likely to be
observed at 25(OH)D levels which are considered higher than that required for normal bone
metabolism.An earlier SARS-CoV-2 negativity may have significant public health benefits in
limiting the spread of the disease. Therefore, we hypothesise that high dose vitamin D
supplementation in patients with COVID-19 and vitamin D deficiency may lead to SARS-CoV-2
negativity in greater proportions of patients associated with decrease in serological markers
of inflammation.
Description:
The role of therapeutic vitamin D supplementation in asymptomatic individuals with vitamin-D
deficiency and COVID-19 is not known. Immune-modulatory effect of vitamin D is likely to be
observed at 25(OH)D levels which are considered higher than that required for normal bone
metabolism.[6] An earlier SARS-CoV-2 negativity may have significant public health benefits
in limiting the spread of the disease. Therefore, we hypothesise that high dose vitamin D
supplementation in patients with COVID-19 and vitamin D deficiency may lead to SARS-CoV-2
negativity in greater proportions of patients associated with decrease in serological markers
of inflammation.
Methods: Consecutive individuals with SARS-CoV-2 infection who were mildly symptomatic or
asymptomatic with or without co-morbidities (hypertension, diabetes mellitus, chronic
obstructive airway disease, chronic liver disease) admitted to tertiary care hospital in
north India were invited for the study. A written consent was obtained from all patients
included in the study and protocol was approved by the Institute Ethics Committee.
Patients with vitamin D deficiency defined as 25 (OH)D level<20 ng/ml were randomized to
receive daily 60,000IU of cholecalciferol (5 ml oral solution in nano droplet form) for seven
days in the "intervention arm" or to receive a single dose of 60,000 IU vitamin D
supplementation at admission in the "control arm". Patients unable to take oral
supplementation like those requiring invasive ventilation were excluded. Subsequently,
25(OH)D levels were assessed at day 7 and a weekly supplementation of 60,000IU provided to
those with 25(OH)D >50 ng/ml or continued on daily vitamin D 60,000 IU supplementation for
another seven days in participants with 25 (OH)D<50ng/ml (day-14) in the intervention arm. No
vitamin D supplementation was provided in the control arm other than the initial dose at
hospital admission.
25 (OH)D, serum calcium, phosphorus, fibrinogen , d-dimer, C-reactive protein, procalcitonin,
renal and liver function tests were performed periodically up till day-21 or virus
negativity, whichever occurred earlier. Oro-pharyngeal swabs were obtained for SARS-CoV-2 RNA
detection at day-5, 7, 10, 14, 18 and 21 and detection was performed by real-time polymerase
chain reaction (RT-PCR), CFX-96 IVD, Bio-Rad. 25 (OH)D was analysed by
electrochemiluminescence immunoassay (ECLIA) (Roche Cobas E 801 Analyzer; Roche Diagnostics),
using the kit supplied by the same manufacturer (Elecsys Total Vitamin D, version 2.0). Serum
calcium (N, 8.5-10.2 mg/dl) and C-reactive protein (N, 0-5 mg/l) were processed by ECLIA
method using Roche Cobas 8000, Roche Diagnostics. D dimer (N, 0-240 ng/ml) & fibrinogen (N,
2-4g/l) were analyzed using Stago Compact/ Stago STA R model, Diagnostica Stago, Inc, USA
respectively.
