Nicotinamide Riboside in Hospitalized Patients

NCT04110028 | Completed Phase 1 DMC

• 1 other identifier: 2017/1334C
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammation; Acute Illness

Keywords

Nicotinamide riboside; NAD+; Epigenetics; Aging; PARP

Outcome Measures

Primary Outcomes (1)

• Length of stay from randomization to discharge from hospital to home or to an institution with a lower care level than a hospital for instance a long term care facility.

  Days

  Up to 90 days

Secondary Outcomes (37)

• Time to normalization of urine production

  Up to 90 days

• Mortality

  At 90 days, 65 weeks and 10 years

• Length of stay from randomization to medically fit for discharge from hospital to home or to an institution with a lower care level than a hospital for instance a long term care facility.

  Up to 90 days

• Time to normalization of blood pressure

  Up to 90 days

• Change in blood pressure during the study period

  Baseline and 90 days and 65 weeks

Other Outcomes (8)

• Subgroup analysis - gender

  Ut to 90 days

• Subgroup analysis - age

  Ut to 90 days

• Subgroup analysis - epigenetic age

  Ut to 90 days

Study Arms (8)

Nicotinamide riboside 250 mg

EXPERIMENTAL

One capsule of 250 mg each morning for three months

Drug: Nicotinamide riboside

Nicotinamide riboside 500 mg

EXPERIMENTAL

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

Drug: Nicotinamide riboside

Nicotinamide riboside 1000 mg

EXPERIMENTAL

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

Drug: Nicotinamide riboside

Nicotinamide riboside 2000 mg

EXPERIMENTAL

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

Drug: Nicotinamide riboside

Placebo for 250 mg nicotinamide riboside

PLACEBO COMPARATOR

One capsule each morning for three months

Drug: Placebo

Placebo for 500 mg nicotinamide riboside

PLACEBO COMPARATOR

One capsule each morning and afternoon for three months

Drug: Placebo

Placebo for 1000 mg nicotinamide riboside

PLACEBO COMPARATOR

Two capsules each morning and afternoon for three months

Drug: Placebo

Placebo for 2000 mg nicotinamide riboside

PLACEBO COMPARATOR

Four capsules each morning and afternoon for three months

Drug: Placebo

Interventions

Nicotinamide riboside DRUG

Nicotinamide riboside in different doses

Nicotinamide riboside 1000 mg; Nicotinamide riboside 2000 mg; Nicotinamide riboside 250 mg; Nicotinamide riboside 500 mg

Placebo DRUG

Placebo

Placebo for 1000 mg nicotinamide riboside; Placebo for 2000 mg nicotinamide riboside; Placebo for 250 mg nicotinamide riboside; Placebo for 500 mg nicotinamide riboside

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• ChromaDex, Inc.: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Inflammation

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arne Søraas, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The safety committee will have access to unblinded results during the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 1, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)