Nicotinamide Riboside in Hospitalized Patients

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients will receive oral nicotinamide riboside or placebo and clinical and paraclinical outcome will be determined

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: ChromaDex, Inc.
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion criteria:

1. 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).

2. Preferably: Previously included in the Janus Cohort or any other cohort or study with stored biological samples.

Exclusion Criteria:

1. Allergy to NR or ingredients in capsules or placebo.

2. Patients expected to pass away within 90 days.

3. Patients unable to give their consent

4. 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.

5. Pregnancy or breastfeeding *

6. Any cancer not in full remission for >10 years

7. Use of St John's Wort based supplements during the past 30 days

8. Patient has undergone solid organ transplantation

9. Participation in any clinical trial with unknown medications

10. Major gastrointestinal or other internal bleeding past week

11. Logistical challenges after discharge. Patient must be able to attend follow up.

12. The treating physician considers the patient unfit or unable to participate. *All fertile women must have a human chorionic gonadotropin test.