Status:
COMPLETED
Nicotinamide Riboside in Hospitalized Patients
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
ChromaDex, Inc.
Conditions:
Inflammation
Acute Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients will receive oral nicotinamide riboside or placebo and clinical and paraclinical outcome will be determined
Detailed Description
Patients experiencing acute illness will often have a prolonged recovery time. The cause of this is unknown, but certain factors, like age, duration, and graveness of the illness, is associated with p...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults \> 18 years old, admitted to hospital with tissue damage, can be included when they are considered medically stable though still expected to remain hospitalized for at least 7 more days (from inclusion).
- Preferably: Previously included in the Janus Cohort or any other cohort or study with stored biological samples.
- Exclusion Criteria:
- Allergy to NR or ingredients in capsules or placebo.
- Patients expected to pass away within 90 days.
- Patients unable to give their consent
- Unstable patients:
- i. Uncontrolled infection (clinical septicaemia, inadequate response to treatment, inadequate control of source of infection or at treating physician's discretion).
- ii. Mean arterial pressure \<70 mm Hg and symptoms of hypotension. iii. Patients requiring dialysis at the time of inclusion or glomerular filtration rate \<40 iv. Liver failure with Child-Pugh class B or C or any class associated with hepatic encephalopathy (any grade), alanin aminotransferase or aspartate aminotransferase \>3 times upper limit v. Moderate to severe peripheral oedema and/or pulmonary oedema, any unstable cardiac rhythm, myocardial infarction with peak TNT \>300 past week. Signs of elevated intracranial pressure (headache, vomiting and depressed global consciousness in conjunction with focal neurological signs, papilledema, spontaneous periorbital bruising and a triad of bradycardia, respiratory depression and hypertension).
- vi. Arterial pH \<7.30 or \>7.50 vii. Serum potassium under 3,2 or over 5 mmol/L.
- Pregnancy or breastfeeding \*
- Any cancer not in full remission for \>10 years
- Use of St John's Wort based supplements during the past 30 days
- Patient has undergone solid organ transplantation
- Participation in any clinical trial with unknown medications
- Major gastrointestinal or other internal bleeding past week
- Logistical challenges after discharge. Patient must be able to attend follow up.
- The treating physician considers the patient unfit or unable to participate. \*All fertile women must have a human chorionic gonadotropin test.
Exclusion
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04110028
Start Date
October 1 2019
End Date
December 1 2023
Last Update
May 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oslo University Hospital
Oslo, Norway, 0450