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Trial - NCT04818216


Column Value
Trial registration number NCT04818216
Full text link
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04818216

First author
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-26

Recruitment status
Last imported at : July 12, 2023, 8 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

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

multi-center

Study aim
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: provision of signed and dated informed consent form from a participant or legally authorized representative (lar); male or female, >18 years old; hospitalized participants with a laboratory diagnosis of covid-19 infection evidence of persistent aki as defined by the kidney disease: improving global outcomes (kdigo) guidelines (table 3); willing to adhere to the study intervention regimen;

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

hypersensitivity to nicotinamide riboside (nr); pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements; egfr <15 ml/min/1.73 m2 as per the chronic kidney disease epidemiology collaboration equation at admission lab; maintenance renal replacement therapy or initiation of renal replacement therapy before randomization currently on nr or nicotinamide or vitamin b3 (niacin) supplementation (multivitamins are allowed); concomitant cirrhosis of liver or acute liver failure; any medical history or condition that might, in the opinion of the attending physician, put the participant at significant risk if he/she were to participate in the trial; individuals with kidney transplant; individuals with blood platelet count <100,000/microl

Number of arms
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

The University of Texas Health Science Center at San Antonio

Inclusion age min
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : Sept. 10, 2023, midnight
Source : ClinicalTrials.gov

28

primary outcome
Last imported at : Dec. 27, 2023, 4 p.m.
Source : ClinicalTrials.gov

Change in Whole Blood NAD+ Level;Number of Participants With Adverse Events of Grade 3 or Higher;Occurrence of Thrombocytopenia

Notes
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : March 28, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 885, "treatment_name": "Nicotinamide", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]