| Trial registration number
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CTRI/2021/08/035709 |
Full text link
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59515
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First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Pinaki Dutta
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Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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drpinakidutta12@gmail.com
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Registration date
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-08-17
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Recruitment status
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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a)Adults enrolling for the 1st dose of COVISHIELD vaccine and consenting to participate <br/ >b)Age between 18 to 60 years <br/ >
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Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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a)Pregnancy/Lactation <br/ >b)Those on chronic glucocorticoid therapy ( >5mg/d in prior 3 months) <br/ >c)HIV or other known immunodeficiency <br/ >d)CKD/ESRD <br/ >e)25(OH)D >30ng/ml at baseline <br/ >f)IgG to spike protein >800mU/ml <br/ >g)Malignancy/ Lymphoma <br/ >h)Psychiatric illness <br/ >i)Other immunosuppressive treatment <br/ >j)Hypercalcemia ( >10.2mg/dl) <br/ >k)Not consenting <br/ >
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Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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SEHEAC New Delhi
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Inclusion age min
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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India
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Type of patients
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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400
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primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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To evaluate the impact of calcifediol supplementation on the efficacy of ChAdOx1 nCoV- 19 vaccine in terms of both humoral and cell-mediated; anti-SARS-CoV-2 immunityTimepoint: Baseline; 3; 4 and 6 months from baseline
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Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 244, "treatment_name": "Calcifediol", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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