Actively Recruiting

Phase 2
Age: 10Years - 30Years
All Genders
ID05194397

Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors

Led by Children's Hospital of Philadelphia · Updated on 2025-12-04

80

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Children's Hospital of Philadelphia

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Adolescents and young adults (AYAs) who have had hematopoietic cell transplantation (HCT) are at higher risk for early loss of muscle mass, which increases their risk of death and cardiovascular disease. Researchers are studying the effects of a dietary supplement called nicotinamide riboside (NR), a precursor of NAD+, along with a home-based exercise program, on muscle strength and aerobic fitness in AYA HCT survivors. This is a randomized, placebo-controlled trial with a 2x2 factorial design to evaluate these interventions over 16 weeks. Participants will be assigned to one of four groups: NR supplement alone, placebo alone, exercise plus NR, or exercise plus placebo. NR dosing varies by body weight, ranging from 300 mg to 900 mg once daily for 16 weeks. The exercise program includes aerobic and resistance training, aiming for 150-300 minutes of moderate aerobic activity per week and strength training twice weekly. The placebo matches the NR capsules but contains no active supplement. Participants will be monitored for changes in muscle strength using tests like isometric knee extension, ankle plantarflexion, and grip strength. Muscle mass and muscle energy metabolism will also be assessed along with aerobic capacity (VO2 max) from baseline to 16 weeks. Safety and adherence will be tracked, and the study includes multiple assessments over the 16-week period to evaluate the effects of the interventions on muscle quality and fitness.

CONDITIONS

Brief Title

Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors

Who Can Participate

Age: 10Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females, ages 10 to 30 years at enrollment
  • Able to understand and speak English
  • Diagnosis of leukemia (myeloid or lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT
  • 6 to 48 months from allogeneic HCT
  • Females must have a negative pregnancy test and use contraception or abstinence during the study
  • Informed consent or parental permission and child assent as appropriate
  • Minimum weight of 24 kg
Not Eligible

You will not qualify if you...

  • Known sensitivity to nicotinamide riboside (NR)
  • Use of medications increasing NR toxicity risk, including statins
  • Active malignancy, investigational agents within 4 weeks, or high-dose glucocorticoids at baseline
  • Currently meeting public health exercise guidelines
  • Use of NAD+ precursors at supra-physiologic doses within 4 weeks
  • Hemoglobin less than 10 g/dL
  • Platelet count less than 50,000
  • Diabetes requiring insulin or insulin secretagogues
  • HbA1C 8% or higher or fasting glucose over 125 mg/dL (both must be met if diabetic)
  • Kidney disease with eGFR below 60 ml/min/1.73 m2
  • Liver disease with ALT or AST over 3 times the upper limit of normal
  • Physical limitations preventing exercise testing or training
  • Recent unstable angina or heart attack within 5 days
  • Recurrent fainting
  • Severe aortic stenosis symptoms
  • Uncontrolled symptomatic arrhythmia
  • Pulmonary embolus within 3 months
  • Lower extremity thrombosis
  • Moderate or severe persistent asthma
  • Resting oxygen saturation less than 85%
  • Pregnancy or planning pregnancy
  • Non-cardiopulmonary disorders affecting exercise or worsened by exercise
  • Possible non-compliance with study procedures
  • Contraindications to MRI (but MRI inability alone does not exclude participation in other parts)
  • Weight that prevents safe completion of study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 16 weeks

Participants undergo a 16-week intervention involving daily nicotinamide riboside or matched placebo supplementation based on body weight, and/or a home-based remotely supervised exercise program including aerobic and strengthening exercises designed to gradually increase activity levels.

Weekly visits for up to 16 weeks

Trial Site Locations

Total: 3 locations

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

2

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

3

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

Loading map...

Research Team

K

Katherine Cambareri, MPH

K

Kristin Wade

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

Similar Trials

Use of [F-18] FLT for Imaging With Positron Emission Tomogra...

Brain and Central Nervous System Tumors

Actively Recruiting

1 location

Proof-Of-Concept Study of Metabolically Optimized, Non-Cytot...

Myelodysplastic Syndromes

Actively Recruiting

1 location

A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study ...

Myelodysplastic Syndromes

Actively Recruiting

71 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Exercise training and NR supplementation to improve muscle mass and fitness in adolescent and young adult hematopoietic cell transplant survivors: a randomized controlled trial {1}.

Minkeun Song, Saro H Armenian, Rusha Bhandari...

https://pubmed.ncbi.nlm.nih.gov/35854224