Skip to main content
OpenTrials
Completed

NCT Number: NCT05126602

Vitamin D Supplementation and Clinical Improvement in COVID-19

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 76124, Indonesia

About this study

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

  • Descriptive statistics
  • Repeated measures ANOVA
  • a Linear mixed model or generalized estimated equation will be applied to adjust the variables in the baseline

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3 10000 IU

Dietary Supplement

Tablet of 5000 IU of vitamin D3 given twice daily

Other names: Hi-D Cholecalciferol 5000

Vitamin D3 1000 IU

Dietary Supplement

Tablet of 1000 IU of vitamin D3 given once daily

Other names: Hi-D Cholecalciferol 1000

Primary outcomes

  1. Clinical Recovery Time

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

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

  2. Length of Stay

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

    Defined as the duration of receiving hospital care

  3. PCR Conversion time

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

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

  4. Platelet to Lymphocyte Ratio / PLR in blood

    Time frame: Changes of PLR value from baseline to one week

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

  5. Total Lymphocyte Count (TLC) in blood

    Time frame: Changes of TLC value from baseline to one week

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

  6. Neutrophil-Lymphocyte Ratio (NLR) in blood

    Time frame: Changes of TLC value from baseline to one week

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

  7. D-Dimer

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

    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

Sponsors and collaborators

Lead sponsor

Bumi Herman

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.