AzTrials
AzTrials

COVID-19NCT05126602

Vitamin D Supplementation and Clinical Improvement in COVID-19

A study testing Vitamin D3 10000 IU and Vitamin D3 1000 IU in people with COVID-19, run by Bumi Herman at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Vitamin D3 10000 IU and Vitamin D3 1000 IU
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndonesia
Study dates
1 Apr 2021to 1 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion Criteria:
  2. Belongs to moderate case
  3. Diagnosed using PCR test
  4. Showing a vitamin D deficiency (<30 ng/dL).
  5. Exclusion Criteria
  6. Pregnant or doing breastfeeding
  7. Patient under specific medication (Tuberculosis, or HIV, or malignancy) or undergo hemodialysis
  8. Receive vitamin D supplementation prior to allocation.
  9. Tested negative less than 5 days after receiving vitamin D
  10. Creatinine >2,0 mg/dL
  11. Blood Calcium >10,5 mg/dL.
  12. Ventilated
  13. Hypersensitive to vitamin D
  14. Consistent desaturation <85% with oxygen supplementation and require High-Flow Nasal Cannula (HFNC)/Extracorporeal membrane Oxygenation (ECMO) via a ventilator.
  15. Refuse to attend blood examination for follow up

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Wahidin Sudirohusodo General Hospital

    Makassar, South Sulawesi, 76124

Other trials in Indonesia

About this study

Official title: Vitamin D Supplementation and Changes of Hematology Parameter, Coagulation Profile, and Clinical Improvement Among COVID-19 Patients

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

Read the detailed description

Population:

The COVID 19 patients admitted to hospital with moderate severity, defined as Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air at sea level.

Methodology:

A double-blind randomized clinical trial allocated with simple random sampling

Intervention:

5000 International unit/ IU of vitamin D3 (Cholecalciferol) given orally twice daily (total 10000 IU per day)

Comparison group:

1000 International unit/ IU of vitamin D3 (Cholecalciferol) given once daily

Variables to be collected :

  • The level of 25-hydroxyvitamin D in the blood
  • D-Dimer
  • Platelet-to-Lymphocyte Ratio (PLR)
  • Total Lymphocyte Count (TLC)
  • Neutrophil to Lymphocyte Ratio (NLR)
  • Age
  • Sex
  • Comorbidities including chronic diseases
  • Body Mass Index
  • Handgrips Strength
  • Anticoagulant administration
  • Clinical Symptoms and days to recover
  • Length of Stay
  • Time to PCR conversion where the PCR is conducted every two days

Sample size and recruitment

Following the study in Saudi Arabia, the sample size was derived from the days to achieve recovery, where the group who received the 5000 D had an average recovery day of 6.2 ± 0.8. The intervention is expected to shorten the average recovery days up to 10%. Using the difference between the two means, the effect size derived from this result is 0.775. With 5% type 1 error and 90% power and equal allocation (1:1), the number needed for each group is 30 participants

Participants are allocated consecutively according to the permutation of the simple random sampling.

Proposed statistical analysis

  1. Descriptive statistics
  2. Repeated measures ANOVA
  3. a Linear mixed model or generalized estimated equation will be applied to adjust the variables in the baseline
Conditions
COVID-19
Being tested
Vitamin D3 10000 IU, Vitamin D3 1000 IU
Keywords
Vitamin D, Hematology parameter, COVID-19, PCR Conversion, D-Dimer, Clinical Recovery
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3 10000 IUDietary supplement

    Also called Hi-D Cholecalciferol 5000

    Tablet of 5000 IU of vitamin D3 given twice daily

  • Vitamin D3 1000 IUDietary supplement

    Also called Hi-D Cholecalciferol 1000

    Tablet of 1000 IU of vitamin D3 given once daily

Study groups in NCT05126602
Study groupRoleWhat they receive
High Dose Vitamin D3ExperimentalA chewing tablet of 5000 IU of vitamin D3 is given twice daily, orally in the morning and evening for two weeks
Receives: Dietary Supplement: Vitamin D3 10000 IU
Low Dose Vitamin D3Active comparatorA chewing tablet of 1000 IU of vitamin D3 is given once daily, orally in the morning for two weeks
Receives: Dietary Supplement: Vitamin D3 1000 IU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Recovery Time

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

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

  2. Length of Stay

    Defined as the duration of receiving hospital care

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

  3. PCR Conversion time

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

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

  4. Platelet to Lymphocyte Ratio / PLR in blood

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

    Measured: Changes of PLR value from baseline to one week

  5. 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

    Measured: Changes of TLC value from baseline to one week

  6. 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

    Measured: Changes of TLC value from baseline to one week

  7. 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

    Measured: Changes of D-dimer value from baseline to one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Sep 2021
  4. Study completion1 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05126602
Sponsor's protocol ID
0411212204
Status last verified
Nov 2021
First submitted
12 Nov 2021
Last updated
19 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No data sharing will be done

Publications

  • 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.

    PubMed 32605780

  • 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.

    PubMed 32880651

  • 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.

    PubMed 32304994

  • 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.

    PubMed 32665858

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 10000 IU and Vitamin D3 1000 IU in people with COVID-19, run by Bumi Herman at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Recovery Time (time frame: from baseline to the time when the symptoms disappear, assessed for up to 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05126602, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.

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