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Trial - NCT05126602


Column Value
Trial registration number NCT05126602
Full text link
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Sisca Agustia

Contact
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

2021-11-19

Recruitment status
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: belongs to moderate case diagnosed using pcr test showing a vitamin d deficiency (<30 ng/dl). exclusion criteria 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. ventilated 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

Exclusion criteria
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Bumi Herman

Inclusion age min
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Indonesia

Type of patients
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Clinical Recovery Time;D-Dimer;Length of Stay;Neutrophil-Lymphocyte Ratio (NLR) in blood;PCR Conversion time;Platelet to Lymphocyte Ratio / PLR in blood;Total Lymphocyte Count (TLC) in blood

Notes
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Nov. 19, 2021, 7:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1000 IU", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "5000 IU ", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]