Vitamin D Supplementation and Clinical Improvement in COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126602
• Other study ID #: 0411212204
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: Hasanuddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

1. Inclusion Criteria:

1. Belongs to moderate case

2. Diagnosed using PCR test

3. Showing a vitamin D deficiency (<30 ng/dL).

2. Exclusion Criteria

1. Pregnant or doing breastfeeding

2. Patient under specific medication (Tuberculosis, or HIV, or malignancy) or undergo hemodialysis

3. Receive vitamin D supplementation prior to allocation.

4. Tested negative less than 5 days after receiving vitamin D

5. Creatinine >2,0 mg/dL

6. Blood Calcium >10,5 mg/dL.

7. Ventilated

8. Hypersensitive to vitamin D

9. Consistent desaturation <85% with oxygen supplementation and require High-Flow Nasal Cannula (HFNC)/Extracorporeal membrane Oxygenation (ECMO) via a ventilator.

10. Refuse to attend blood examination for follow up

Related Conditions & MeSH terms

• COVID-19

Intervention

Dietary Supplement:
• Vitamin D3 10000 IU
Tablet of 5000 IU of vitamin D3 given twice daily
• Vitamin D3 1000 IU
Tablet of 1000 IU of vitamin D3 given once daily

Locations

Country	Name	City	State
Indonesia	Wahidin Sudirohusodo General Hospital	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Bumi Herman

Country where clinical trial is conducted

Indonesia, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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