Short Term, High Dose Vitamin D Supplementation for COVID-19
NCT ID: NCT04459247
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2020-06-15
2021-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Vitamin D high dose
Vit D
Oral liquid formulation of 60000 IU
Control arm
No Vitamin D supplementation
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vit D
Oral liquid formulation of 60000 IU
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ashu Rastogi
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deptt of Endocrinology
Chandigarh, , India
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043.
Rastogi A, Bhansali A, Khare N, Suri V, Yaddanapudi N, Sachdeva N, Puri GD, Malhotra P. Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study). Postgrad Med J. 2022 Feb;98(1156):87-90. doi: 10.1136/postgradmedj-2020-139065. Epub 2020 Nov 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
121/20
Identifier Type: -
Identifier Source: org_study_id