Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

What Was Tested

This registered early phase 1 trial tested NAD+.

It had 1 arm (groups): Nicotinamide riboside (NR) (experimental).

The registry classes the interventions as drug.

More on the Plan

Engraftment is defined as the process during which transplanted stem cells begin to grow in the bone marrow and produce new white blood cells, red blood cells, and platelets.

It takes about 14 to 24 days for donor cells to engraft after infusion, and the time between which blood counts fall to the time when they recover is a very critical period.

The primary objectives of this study is to evaluate safety and tolerability of NR supplementation The secondary objective of this study is to evaluate neutrophil and platelet recovery after HCT.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: All disease indications for allogeneic hematopoietic cell transplantation except for myelofibrosis. Subject must meet program eligibility criteria\* for myeloablative conditioning alloHCT and plan to undergo myeloablative conditioning. HLA-identical related donor or unrelated human donor source with bone marrow graft. Subjects must provide a written informed consent.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: history of allergy or intolerance to nr precursor compounds, including niacin or nicotinamide; pregnant or breastfeeding women are excluded from this study since allogeneic hct is a strict contraindication; subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the NAD+ study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-05-19 with completion listed for 2026-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug (time frame: day +7). Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug (time frame: day +14). Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug (time frame: day +21).

It also tracked 2 secondary outcomes, for example Median days to neutrophil recovery after HCT and Median days to platelet recovery after HCT.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of NAD+ in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.