Vitamin D Supplementation and Changes of Hematology Parameter, Coagulation Profile, and Clinical Improvement Among COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Neutrophil-Lymphocyte Ratio (NLR) in blood
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Belongs to moderate case
- •Diagnosed using PCR test
- •Showing a vitamin D deficiency (<30 ng/dL).
排除标准
- •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.
- •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
结局指标
主要结局
Neutrophil-Lymphocyte Ratio (NLR) in blood
时间窗: 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
Length of Stay
时间窗: from the admission time to the time of hospital discharge, assessed for up to 3 months
Defined as the duration of receiving hospital care
Total Lymphocyte Count (TLC) in blood
时间窗: 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
Clinical Recovery Time
时间窗: 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)
PCR Conversion time
时间窗: 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
D-Dimer
时间窗: 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
Platelet to Lymphocyte Ratio / PLR in blood
时间窗: 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
次要结局
未报告次要终点
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University