Nicotinamide Riboside in Hospitalized Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-12-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Inflammation Acute Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Participants will be randomized to placebo or nicotinamide riboside (NR) in increasing doses. The safety of each dose will be evaluated before commencing the next phase. In each phase nicotinamide or placebo will be administered.

The patients will use NR for 90 days. When all patients have completed their NR treatment the study will be unblinded and the follow-up visits at one year later and further on will be unblinded.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The safety committee will have access to unblinded results during the study.

Study Groups

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Nicotinamide riboside 250 mg

One capsule of 250 mg each morning for three months

Group Type EXPERIMENTAL

Nicotinamide riboside

Intervention Type DRUG

Nicotinamide riboside in different doses

Nicotinamide riboside 500 mg

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

Group Type EXPERIMENTAL

Nicotinamide riboside

Intervention Type DRUG

Nicotinamide riboside in different doses

Nicotinamide riboside 1000 mg

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

Group Type EXPERIMENTAL

Nicotinamide riboside

Intervention Type DRUG

Nicotinamide riboside in different doses

Nicotinamide riboside 2000 mg

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

Group Type EXPERIMENTAL

Nicotinamide riboside

Intervention Type DRUG

Nicotinamide riboside in different doses

Placebo for 250 mg nicotinamide riboside

One capsule each morning for three months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Placebo for 500 mg nicotinamide riboside

One capsule each morning and afternoon for three months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Placebo for 1000 mg nicotinamide riboside

Two capsules each morning and afternoon for three months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Placebo for 2000 mg nicotinamide riboside

Four capsules each morning and afternoon for three months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Nicotinamide riboside

Nicotinamide riboside in different doses

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No