Recruiting
Phase 1

BasisTM

Sponsor:

Elysium Health

Code:

NCT03635411

Conditions

Recovery of Function

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Nicotinamide Riboside and Pterostilbene

Placebo

Study Details

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

.

Conditions

Recovery of Function

Study ID

NCT03635411

Start date

Dec 6, 2018

Status verified date

Jan, 2020

Completion date

Dec, 2020

Anticipated

Primary completion date

Nov, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 65 year old
2. Patient presenting to trauma bay

Exclusion Criteria:

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Basis

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

placebo comparator: Placebo

Placebo given twice daily for 90 days

Interventions

Nicotinamide Riboside and Pterostilbene

Nicotinamide riboside and pterostilbene manufactured by Basis

Placebo

Sugar pill manufactured to mimic Basis supplement.

Primary outcome measure

  • Complications [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

Elysium Health

Last update posted

Jan 6, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Elysium Health on 2020-01-06.