Table 1.
Timeline and applied tests.
| Time Point | weeks | ||
|---|---|---|---|
| 0 | 2 | 4 | |
| Enrolment | ✓ | ||
| Eligibility screening | ✓ | ||
| Informed consent | ✓ | ||
| Randomization | ✓ | ||
| Allocation | ✓ | ||
| Intervention Treatment: 50.000 IU soft gel (single dose) and 10.000 IU daily drop daily | ✓ | ||
|
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| Control: placebo soft gel (single dose) + 1000 IU drop daily |
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||
| Compliance and side effect |
|
||
| Laboratory assessment | ✓ | ✓ | |
| Inflammatory markers (hs-CRP, ESR, RDW, NLR, PLR) | ✓ | ✓ | |
| Renal function tests (Cr, Urea) | ✓ | ✓ | |
| Liver function tests (LDH,AST,ALT,GGT) | ✓ | ✓ | |
| Lipid profile (LDL-c, HDL-c,TG, Total cholesterol) | ✓ | ✓ | |
| Fasting blood glucose | ✓ | ✓ | |
| Ca, P, Albumin, 25(OH)D | ✓ | ✓ | |
| SF-36 and NYHA questionnaire | ✓ | ✓ | |
Fasting blood glucose (FBG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine (Cr), calcium (Ca), phosphate (P), High sensitive C-Reactive Protein (hs-CRP), Erythrocyte sedimentation rate (ESR), Red Cell Distribution Width (RDW), Neutrophil-to-lymphocyte ratio (NLR), Platelet-to-lymphocyte ratio (PLR), Low-density lipoprotein cholestrol (LDL-c), High-density lipoprotein cholesterol (HDL-c), Triglycerides (TG).