NCT03635411

Brief Summary

Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET) A phase I, randomized, double-blind, placebo-controlled, single institutional pilot trial investigating the impact of nicotinamide riboside/pterstilbene (BasisTM) on functional recovery after traumatic fall in elderly patients .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

August 7, 2018

Last Update Submit

January 3, 2020

Conditions

Recovery of Function

Outcome Measures

Primary Outcomes (1)

  • Complications

    To analyze patient complications through daily adverse event monitoring and summarize adverse events for each arm

    90 days

Secondary Outcomes (15)

  • Grip Strength Scores

    90 days

  • Inhalation Volume Measurements

    90 days

  • 6 Minute Timed Walk Test Scores

    90 days

  • Timed Get Up and Go Test Scores

    90 days

  • Measurement of Muscle/ Fat Ratio

    90 days

  • +10 more secondary outcomes

Study Arms (2)

Basis

EXPERIMENTAL

Nicotinamide riboside 500 mg and pterostilbene 100 mg given twice daily in divided doses for 90 days

Dietary Supplement: Nicotinamide Riboside and Pterostilbene

Placebo

PLACEBO COMPARATOR

Placebo given twice daily for 90 days

Dietary Supplement: Placebo

Interventions

Nicotinamide Riboside and PterostilbeneDIETARY_SUPPLEMENT

Nicotinamide riboside and pterostilbene manufactured by Basis

Also known as: Basis, NRPT
Basis
PlaceboDIETARY_SUPPLEMENT

Sugar pill manufactured to mimic Basis supplement.

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 65 year old
  • Patient presenting to trauma bay

You may not qualify if:

  • Currently taking medication for severe to moderate dementia (see Appendix 9)
  • Currently taking niacin, nicotinic acid, nicotinamide, or nicotinamide riboside
  • Pre-existing immobility (wheel chair or bed bound)
  • Renal failure requiring hemodialysis or peritoneal dialysis
  • End-stage Liver Disease (Model for End Stage Liver Disease Score ≥ 25) (see Appendix 11)
  • Intubated prior to enrollment (excluding intubation for surgery)
  • More than 48 hours post-injury
  • Thoracic Anatomic Injury Score \> 3 (see Appendix 10)
  • Other Injuries with Anatomic Injury Score \>2, excluding thorax (see Appendix 10)
  • Hip fractures
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

nicotinamide-beta-ribosidePterocarpus marsupiumRadial Basis Function Networks

Intervention Hierarchy (Ancestors)

Neural Networks, ComputerMathematical Concepts

Study Officials

  • Carrie Sims

    Univeristy of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie Sims

CONTACT

215-662-8819carrie.sims@uphs.upenn.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Assessing Safety and Tolerability
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 17, 2018

Study Start

December 6, 2018

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)