Effect of Vitamin D supplementation on immune response following COVID vaccine

Effect of Vitamin D supplementation on the immune repertoire in recipients of the ChAdOx1 nCoV- 19 vaccine: A prospective randomised, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035709

Enrollment

400

Registered

2021-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
a)To determine the percentage of responders (neutralising antibodies 800mU/ml) four weeks after the 2nd dose (complete vaccination)Timepoint: 4 months from baseline;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;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	—

Measure

Time frame

a)To determine the percentage of responders (neutralising antibodies 800mU/ml) four weeks after the 2nd dose (complete vaccination)Timepoint: 4 months from baseline;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;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

—

Countries

India

Contacts

Public ContactDr Pinaki Dutta

PGIMER, Chandigarh

drpinakidutta12@gmail.com9357114777

Outcome results