Vitamin D Supplementation and Clinical Improvement in COVID-19

NCT05126602 | Completed

• 1 other identifier: 0411212204
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Keywords

Vitamin D; Hematology parameter; COVID-19; PCR Conversion; D-Dimer; Clinical Recovery

Outcome Measures

Primary Outcomes (7)

• Clinical Recovery Time

  Defined as the time where the clinical symptoms resolve completely (including cough and other symptoms of pneumonia)

  from baseline to the time when the symptoms disappear, assessed for up to 3 months

• Length of Stay

  Defined as the duration of receiving hospital care

  from the admission time to the time of hospital discharge, assessed for up to 3 months

• PCR Conversion time

  Defined as the duration of the time to obtain negative result on PCR

  from the time of diagnosis until proven negative in PCR test, assessed for up to 3 months

• Platelet to Lymphocyte Ratio / PLR in blood

  Defined as the ratio of platelet divided by lymphocyte value. A value of \>180 indicates worse prognosis

  Changes of PLR value from baseline to one week

• Total Lymphocyte Count (TLC) in blood

  Defined as the ratio of platelet divided by lymphocyte value. A value of less 2000 cell/ mm3 defined as depletion and indicates worse prognosis

  Changes of TLC value from baseline to one week

• Neutrophil-Lymphocyte Ratio (NLR) in blood

  Defined as the ratio of Neutrophil divided by lymphocyte value. A value of less than 3.13 indicates worse prognosis

  Changes of TLC value from baseline to one week

• D-Dimer

  The D-dimer indicates the degree of fibrin degradation that is associated with blood clot breakage. A value of \>500 ug/L indicates worse outcome

  Changes of D-dimer value from baseline to one week

Study Arms (2)

High Dose Vitamin D3

EXPERIMENTAL

A chewing tablet of 5000 IU of vitamin D3 is given twice daily, orally in the morning and evening for two weeks

Dietary Supplement: Vitamin D3 10000 IU

Low Dose Vitamin D3

ACTIVE COMPARATOR

A chewing tablet of 1000 IU of vitamin D3 is given once daily, orally in the morning for two weeks

Dietary Supplement: Vitamin D3 1000 IU

Interventions

Vitamin D3 10000 IU DIETARY_SUPPLEMENT

Tablet of 5000 IU of vitamin D3 given twice daily

Also known as: Hi-D Cholecalciferol 5000

High Dose Vitamin D3

Vitamin D3 1000 IU DIETARY_SUPPLEMENT

Tablet of 1000 IU of vitamin D3 given once daily

Also known as: Hi-D Cholecalciferol 1000

Low Dose Vitamin D3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Belongs to moderate case
• Diagnosed using PCR test
• Showing a vitamin D deficiency (\<30 ng/dL).

You may not qualify if:

• Pregnant or doing breastfeeding
• Patient under specific medication (Tuberculosis, or HIV, or malignancy) or undergo hemodialysis
• Receive vitamin D supplementation prior to allocation.
• Tested negative less than 5 days after receiving vitamin D
• Creatinine \>2,0 mg/dL
• Blood Calcium \>10,5 mg/dL.
• Ventilated
• Hypersensitive to vitamin D
• Consistent desaturation \<85% with oxygen supplementation and require High-Flow Nasal Cannula (HFNC)/Extracorporeal membrane Oxygenation (ECMO) via a ventilator.
• Refuse to attend blood examination for follow up

Sponsors & Collaborators

• Bumi Herman: lead

Study Sites (1)

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 76124, Indonesia

Location

Related Publications (4)

• Ali N. Role of vitamin D in preventing of COVID-19 infection, progression and severity. J Infect Public Health. 2020 Oct;13(10):1373-1380. doi: 10.1016/j.jiph.2020.06.021. Epub 2020 Jun 20.

  PMID: 32605780 BACKGROUND

• Meltzer DO, Best TJ, Zhang H, Vokes T, Arora V, Solway J. Association of Vitamin D Status and Other Clinical Characteristics With COVID-19 Test Results. JAMA Netw Open. 2020 Sep 1;3(9):e2019722. doi: 10.1001/jamanetworkopen.2020.19722.

  PMID: 32880651 BACKGROUND

• Yang AP, Liu JP, Tao WQ, Li HM. The diagnostic and predictive role of NLR, d-NLR and PLR in COVID-19 patients. Int Immunopharmacol. 2020 Jul;84:106504. doi: 10.1016/j.intimp.2020.106504. Epub 2020 Apr 13.

  PMID: 32304994 BACKGROUND

• Yao Y, Cao J, Wang Q, Shi Q, Liu K, Luo Z, Chen X, Chen S, Yu K, Huang Z, Hu B. D-dimer as a biomarker for disease severity and mortality in COVID-19 patients: a case control study. J Intensive Care. 2020 Jul 10;8:49. doi: 10.1186/s40560-020-00466-z. eCollection 2020.

  PMID: 32665858 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sisca Agustia, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Amirah Faisal, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Zahratul Fajri

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Nurpudji Taslim, Prof

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Suryani Armyn, Prof

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Haerani Rasyid, Prof

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Agussalim Bukhari, Prof

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Irawaty Djaharuddin, Prof

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking for participants is conducted by preparing a similar chewing tablet (appearance including the color and taste). The care provider will not aware as the tablet has been unpacked. Outcome assessors are unaware of the allocation and only statistician knows the allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Two arms trial will be conducted with one group receiving a high dose of vitamin D3 whereas comparison group receiving a low dose of vitamin D3

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 19, 2021
• Study Start: April 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: November 1, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)