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Evaluation of Safety and Dosing of a Vitamin C Bundle for Sepsis Treatment in Africa

NCT04999137 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-09-08

No results posted yet for this study

Summary

Open-label phase 2a Randomized Controlled Trial (RCT) assessing the pharmacokinetics of two different doses of intravenous vitamin C given alongside vitamin B1 in adult medical patients with sepsis and hypotension.

Conditions

Interventions

DRUG

Vitamin C

Vitamin C (ascor), infused intravenously in 50 mls sodium chloride (NaCl) over 30 minutes every 6 hours for 16 doses

DRUG

Vitamin B1

Vitamin B1 (200 mg) administered intravenously every 12 hours for 8 doses

Sponsors & Collaborators

  • Infectious Diseases Institute, Uganda

    collaborator OTHER

  • Walimu

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    lead OTHER

Principal Investigators

  • Shevin T Jacob, MD MPH · LSTM/IDI/Walimu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2021-12-29
Completion
2021-12-29
FDA Drug
Yes

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04999137 on ClinicalTrials.gov