Vitamin D Supplementation and Clinical Improvement in COVID-19
NCT ID: NCT05126602
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-04-01
2021-11-01
Brief Summary
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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
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Vitamin D3 10000 IU
Tablet of 5000 IU of vitamin D3 given twice daily
Low Dose Vitamin D3
A chewing tablet of 1000 IU of vitamin D3 is given once daily, orally in the morning for two weeks
Vitamin D3 1000 IU
Tablet of 1000 IU of vitamin D3 given once daily
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed using PCR test
3. Showing a vitamin D deficiency (\<30 ng/dL).
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Bumi Herman
OTHER
Responsible Party
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Bumi Herman
Assistant Lecturer
Principal Investigators
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Sisca Agustia, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Amirah Faisal, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Zahratul Fajri
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Nurpudji Taslim, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Suryani Armyn, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Haerani Rasyid, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Agussalim Bukhari, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Irawaty Djaharuddin, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Locations
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Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, Indonesia
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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0411212204
Identifier Type: -
Identifier Source: org_study_id