Vitamin D Supplementation and Clinical Improvement in COVID-19

NCT05126602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-11-19

No results posted yet for this study

Summary

Background and objective Vitamin D is important as the interaction between vitamin D and its receptors at the immune cells stimulates innate and adaptive immunity. Deficiency in vitamin D is associated with increased susceptibility to infection and it is commonly found in Indonesia. Several studies indicate the potential of vitamin D supplementation against Coronavirus Disease 2019 (COVID-19), particularly in combating the proinflammatory situation as well as coagulopathy. This study aims to evaluate the supplementation of vitamin D in COVID 19 patients, particularly the changes in hematology parameters and other clinical parameters.

Method A double-blind randomized clinical trial is conducted among moderate COVID 19 patients. High-dose of vitamin D is given orally in the intervention group, compared with a low dose of vitamin D. Hematology parameters, D Dimer, conversion time on Polymerase Chain Reaction (PCR) test, and clinical symptoms are assessed

Hypothesis High Dose vitamin D shows a better hematology parameter, short PCR conversion time, and faster clinical recovery

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 10000 IU

Tablet of 5000 IU of vitamin D3 given twice daily

DIETARY_SUPPLEMENT

Vitamin D3 1000 IU

Tablet of 1000 IU of vitamin D3 given once daily

Sponsors & Collaborators

  • Bumi Herman

    lead OTHER

Principal Investigators

  • Sisca Agustia, MD · Hasanuddin University

  • Amirah Faisal, MD · Hasanuddin University

  • Zahratul Fajri · Hasanuddin University

  • Nurpudji Taslim, Prof · Hasanuddin University

  • Suryani Armyn, Prof · Hasanuddin University

  • Haerani Rasyid, Prof · Hasanuddin University

  • Agussalim Bukhari, Prof · Hasanuddin University

  • Irawaty Djaharuddin, Prof · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-09-30
Completion
2021-11-01

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05126602 on ClinicalTrials.gov