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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2021/08/035709 |
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Date of registration:
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17-08-2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Vitamin D supplementation on immune response following COVID vaccine
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Scientific title:
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Effect of Vitamin D supplementation on the immune repertoire in recipients of the ChAdOx1 nCoV- 19 vaccine: A prospective randomised, placebo-controlled trial |
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Date of first enrolment:
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26-08-2021 |
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Target sample size:
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400 |
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Recruitment status: |
Not Yet Recruiting |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59515 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant and Outcome Assessor Blinded
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Phase:
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Phase 3
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Pinaki Dutta
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Address:
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Department of Endocrinology, Room - 1012,
Nehru Extension Block,
PGIMER, Chandigarh
160012
Chandigarh, CHANDIGARH
India |
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Telephone:
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9357114777 |
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Email:
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drpinakidutta12@gmail.com |
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Affiliation:
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PGIMER, Chandigarh |
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Name:
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Dr Pinaki Dutta
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Address:
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Department of Endocrinology, Room number-1012,
Nehru Extension Block,
PGIMER, Chandigarh
160012
Chandigarh, CHANDIGARH
India |
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Telephone:
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9357114777 |
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Email:
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drpinakidutta12@gmail.com |
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Affiliation:
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PGIMER, Chandigarh |
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Key inclusion & exclusion criteria
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Inclusion criteria: a)Adults enrolling for the 1st dose of COVISHIELD vaccine and consenting to participate
b)Age between 18 to 60 years
Exclusion criteria: a)Pregnancy/Lactation
b)Those on chronic glucocorticoid therapy ( >5mg/d in prior 3 months)
c)HIV or other known immunodeficiency
d)CKD/ESRD
e)25(OH)D >30ng/ml at baseline
f)IgG to spike protein >800mU/ml
g)Malignancy/ Lymphoma
h)Psychiatric illness
i)Other immunosuppressive treatment
j)Hypercalcemia ( >10.2mg/dl)
k)Not consenting
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Intervention(s)
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Intervention1: Calcifediol oral capsules: Calcifediol 50mcg oral capsules daily for 1 month
followed by 25mcg oral capsules daily for 6 months
Control Intervention1: Placebo capsules: Placebo capsules
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Primary Outcome(s)
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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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Secondary Outcome(s)
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a)To determine the percentage of responders (neutralising antibodies 800mU/ml) four weeks after the 2nd dose (complete vaccination)Timepoint: 4 months from baseline
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c)To study changes in calcemic versus anti-SARS-CoV2 immune response between participants being supplemented with calcifediol or placeboTimepoint: 3,4 and 6 months from baseline
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b)To study the changes in calcemic profile including 25(OH)D and PTH in response to calcifediolTimepoint: 1, 3 and 6 months from baseline
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Source(s) of Monetary Support
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SEHEAC, New Delhi
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Site of study- PGIMER, Chandigarh
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Ethics review
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Status: Approved
Approval date: 06/08/2021
Contact:
IEC,PGIMER
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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