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Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET) (BestBet)

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ClinicalTrials.gov Identifier: NCT03635411
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date October 4, 2018
Estimated Study Start Date  ICMJE November 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
Complications [ Time Frame: 90 days ]
To analyze patient complications through daily adverse event monitoring and summarize adverse events for each arm
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03635411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Grip Strength Scores [ Time Frame: 90 days ]
    To measure if BasisTM preserves or improves grip strength using Jamar hand dynamo-meter in non-dominant hand
  • Inhalation Volume Measurements [ Time Frame: 90 days ]
    To measure if BasisTM preserves or improves lung volume by measuring inhaled volumes using incentive spirometry
  • 6 Minute Timed Walk Test Scores [ Time Frame: 90 days ]
    To measure if BasisTM preserves or improves 6 minute Timed Walk Test according to the AmericanThoracic Society Guidelines.
  • Timed Get Up and Go Test Scores [ Time Frame: 90 days ]
    To measure if BasisTM preserves or improves timed get up and go scores
  • Measurement of Muscle/ Fat Ratio [ Time Frame: 90 days ]
    To measure if BasisTM preserves or improves physiologic composition (muscle/fat) ratio) using bioelectric impedance
  • Incidence of Adverse Events [ Time Frame: 90 days ]
    To analyze if BasisTM decreases 90 day incidence of recurrent falls
  • Incidence of Pain and Daily Pain Medication Dosage [ Time Frame: 90 days ]
    To analyze the impact of BasisTM on subjective well-being pain through measurement of pain medication amounts and frequency.
  • Analysis of Quality of Life Scores [ Time Frame: 90 days ]
    To analyze the impact of BasisTM on subjective well-being through analysis of EuroQol 5 Dimensions-5 Levels (EQ-5D-5L) scores and EuroQol Visual Analogue Scale (EQ Vas). EQ-5D-5L Scores consist of 5 sections: Mobility, Self-Care, Usual Activities, Pain/ discomfort and Anxiety/ Depression. The minimum score in each is 1, and the maximum is 5, where 5 indicates extreme problems and 1 indicates no problems. A total of 3125 possible health states exist and each stats is referred to in terms of a 5 digit code. State 11111 indicates no problems on any of the 5 dimensions, whereas state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression. The EQ-VAS is scored from 0 to 100 where 0 means the worst health you can imagine and 100 means the best health you can imagine.
  • Late Life Function and Disability Instrument Scores analysis as a measure of subject independence, function, and disability [ Time Frame: 90 days ]
    To analyze the impact of BasisTM on subjective well-being through analysis of Late Life Function and Disability Scores. Questions are scored on a scale of 5 to 1, where 1 means no difficulties with function and 1 means patients are unable to complete the functions on their own. Disability questions are scored from 1 to 5, where 1 means subjects do not complete activities and feel limited and 5 means subjects can complete activities and don't feel at all limited. Scores are computed using the LLFDI Scoring Software.
  • Analysis of scores on Mini Mental Status Exam as a measure of cognitive function and dementia [ Time Frame: 90 days ]
    To analyze the impact of BasisTM on subjective well-being through analysis of Mini Mental Status Scores. The maximum score is 30 and the sections are orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points), language and praxis (9 points). 0 is the lowest and 30 is the best score.
  • Analysis of subject nutrition through Mini Nutritional Assessment Scores [ Time Frame: 90 days ]
    To analyze the impact of BasisTM on subjective well-being through analysis of Mini Nutritional Assessment scores. The maximum score is 14 points and the lowest (worst score) is 0.
  • Analysis of Subject independence using Barthel Index scores [ Time Frame: 90 days ]
    To analyze the impact of BasisTM on subjective well-being through analysis of Barthel Index Scores. The index consists of 10 Activities of daily living, 8 of which represent activities related to personal care while 2 are related to mobility. The index yields a total score out of 100 with higher scores indicating greater degrees of functional independence.
  • Analysis of patient comorbidities as a measure of adverse events in evaluating Basis tolerability [ Time Frame: 90 days ]
    To analyze the impact of BasisTM on subjective well-being through analysis of Charlson comorbidity index scores. The CCI accounts for 19 pre-defined comorbid conditions and is given a different weight depending on each's association with 1-year mortality. The total score in CCI is determined by the combined weight of the patient's conditions, where higher scores represent worse conditions.
  • Analysis of inflammatory cell activity [ Time Frame: 90 days ]
    To measure if BasisTM alters Nicotinamide adenine dinucleotide (NAD) and sirtuin activity in inflammatory cells. Liquid chromatography mass spectrometry will assay for NAD.
  • Analysis of Mitochondrial Function [ Time Frame: 90 days ]
    Mitochondrial content will be determined by citrate synthase activity. Mitochondrial respiration and the generation of reactive oxygen species will be measured using high-resolution respirometry and fluoremtry.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET)
Official Title  ICMJE Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients
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

.

Detailed Description

This Phase I pilot study will determine if supplementing with the combination of NR and Pter (BasisTM) is well tolerated and will provide the pretrial data necessary to plan a randomized clinical trial aimed at determining if BasisTM improves the functional outcome of injured elderly patients.

Primary Objective

• To determine if BasisTM is well tolerated by elderly patients up to 90 days post injury

Secondary Objectives:

  • To determine if BasisTM preserves or improves muscular strength, endurance, and activity following traumatic injury in elders.
  • To determine if BasisTM preserves or improves physiologic composition (muscle/fat ratio) following traumatic injury in elders.
  • To determine if BasisTM decreases 90 day incidence of recurrent falls
  • To determine the impact of BasisTM on subjective well-being (pain) and quality of life (EQ-5D-5L)
  • To determine if BasisTM alters NAD and sirtuin activity in inflammatory cells.

Elderly trauma patients who present after a traumatic injury will be screened and enrolled within 24 hours of their trauma evaluation. Baseline status will be determined using functional surveys, physical assessments, and physiologic measurements. Patients will be randomized to either BasisTM or placebo for 90 days. Patients will be reassessed at 2 weeks, 6 weeks and 90 days. Activity and heart rate will be monitored continuously using a wrist FitBit Device.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Recovery of Function
Intervention  ICMJE
  • Dietary Supplement: Nicotinamide Riboside and pterostilbene
    Nicotinamide riboside and pterostilbene manufactured by Basis
    Other Name: Basis
  • Drug: Placebo
    Sugar pill manufactured to mimic Basis supplement.
Study Arms  ICMJE
  • Experimental: Basis
    Nicotinamide riboside 500 mg and pterostilbene 100 mg given twice daily in divided doses for 90 days
    Intervention: Dietary Supplement: Nicotinamide Riboside and pterostilbene
  • Placebo Comparator: Placebo
    Placebo given twice daily for 90 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥ 65 year old
  2. Patient presenting to trauma bay
  3. Sustain at least 1 rib fracture
  4. Admitted to the Trauma and Surgical ICU within 24 hours from injury

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 24 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. Lower extremity fractures or pelvic fractures requiring more than 2 weeks of non-weight bearing status
  11. Non-English speaking
  12. Patients who report taking <70% of the study drug/placebo
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carrie Sims 215-662-8819 carrie.sims@uphs.upenn.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03635411
Other Study ID Numbers  ICMJE 829947
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carrie Sims Univeristy of Pennsylvania
PRS Account University of Pennsylvania
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP