COVID-19 Clinical Trial
Official title:
Vitamin D Supplementation and Changes of Hematology Parameter, Coagulation Profile, and Clinical Improvement Among COVID-19 Patients
Verified date | November 2021 |
Source | Hasanuddin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Wahidin Sudirohusodo General Hospital | Makassar | South Sulawesi |
Lead Sponsor | Collaborator |
---|---|
Bumi Herman |
Indonesia,
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
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 |
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