Nicotinamide Riboside in Hospitalized Patients

University of Oslo (UIO)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Inflammation; Acute Illness

Treatments: Drug: Nicotinamide riboside; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04110028

2017/1334C

Details and patient eligibility

About

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

Full 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 prolonged recovery. In this study, we will investigate whether nicotinamide riboside can shorten the recovery phase and improve outcome after acute illness.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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57 participants in 8 patient groups, including a placebo group

Nicotinamide riboside 250 mg

Experimental group

Description:

One capsule of 250 mg each morning for three months

Treatment:

Drug: Nicotinamide riboside

Nicotinamide riboside 500 mg

Experimental group

Description:

One capsule of 250 mg each morning and afternoon for three months

Treatment:

Drug: Nicotinamide riboside

Nicotinamide riboside 1000 mg

Experimental group

Description:

Two capsules of 250 mg each morning and afternoon for three months

Treatment:

Drug: Nicotinamide riboside

Nicotinamide riboside 2000 mg

Experimental group

Description:

Four capsules of 250 mg each morning and afternoon for three months

Treatment:

Drug: Nicotinamide riboside

Placebo for 250 mg nicotinamide riboside

Placebo Comparator group

Description:

One capsule each morning for three months

Treatment:

Drug: Placebo

Placebo for 500 mg nicotinamide riboside

Placebo Comparator group

Description:

One capsule each morning and afternoon for three months

Treatment:

Drug: Placebo

Placebo for 1000 mg nicotinamide riboside

Placebo Comparator group

Description:

Two capsules each morning and afternoon for three months

Treatment:

Drug: Placebo

Placebo for 2000 mg nicotinamide riboside

Placebo Comparator group

Description:

Four capsules each morning and afternoon for three months

Treatment:

Drug: Placebo