Vitamin D Supplementation and Clinical Improvement in COVID-19

Sponsor
Bumi Herman (Other)
Overall Status
Completed
CT.gov ID
NCT05126602
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: Vitamin D3 10000 IU
  • Dietary Supplement: Vitamin D3 1000 IU
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 D3Two 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 (Participant, Investigator, Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Vitamin D Supplementation and Changes of Hematology Parameter, Coagulation Profile, and Clinical Improvement Among COVID-19 Patients
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: High Dose Vitamin D3

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
Tablet of 5000 IU of vitamin D3 given twice daily
Other Names:
  • Hi-D Cholecalciferol 5000
  • Active Comparator: Low Dose Vitamin D3

    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
    Tablet of 1000 IU of vitamin D3 given once daily
    Other Names:
  • Hi-D Cholecalciferol 1000
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical Recovery Time [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 [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 [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Wahidin Sudirohusodo General HospitalMakassarSouth SulawesiIndonesia76124

    Sponsors and Collaborators

    • Bumi Herman

    Investigators

    • Principal Investigator: 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bumi Herman, Assistant Lecturer, Hasanuddin University
    ClinicalTrials.gov Identifier:
    NCT05126602
    Other Study ID Numbers:
    • 0411212204
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bumi Herman, Assistant Lecturer, Hasanuddin University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021