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CompletedNCT03658278Updated Sep 21, 2023

Trauma Screening and Supplementation

An interventional study of Juven in Trauma, Nutritional Deficiency and Wound Heal, sponsored by Michael C Willey. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Michael C Willey · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2018, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The purpose of the proposed study is twofold: 1) The investigators will evaluate ultrasound imaging to screen trauma patients to identify patients at increased risk of postoperative complications associated with sarcopenia. 2) The investigators will evaluate a commercially-available oral nutritional supplement that has previously been evaluated in critically-ill intensive care patients and shown benefit for decreasing complications including decreased wound healing complications, decreased pressure ulcers, decreased skeletal muscle loss due to immobilization, and decreased one-year mortality.

Read the detailed description

Following consent, patients will be assigned a unique study identification number (ID). A master list linking patient ID to patient name and medical record number will be maintained on a password protected and encrypted departmental server location with access limited to research staff. Patients will be randomized by the research team using Microsoft Word random number generator. Patients will not be blinded to their research group, as the experimental nutrition supplementation group will be asked to consume the nutritional supplement daily for a period of two weeks following surgery.

Following consent, the patient's medical record will be reviewed to identify any condition meeting exclusion criteria. If patient meets inclusion criteria we will obtain the following data to be recorded in the research database.

  1. Age
  2. Sex
  3. Height
  4. Weight
  5. BMI
  6. medical comorbidities necessary to calculate Charlson Comorbidity Index (myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disorder, peptic ulcer disease, diabetes without chronic complications, diabetes with chronic complications, hemiplegia or paraplegia, renal disease, any malignancy, metastatic solid tumor, mild liver disease, moderate or severe liver disease, HIV/AIDS
  7. MSSA (methicillin-susceptible Staphylococcus aureus) /MRSA (methicillin-resistant Staphylococcus aureus) nasal colonization status (standard preoperative evaluation)
  8. tobacco use history
  9. history of DVT (deep vein thrombosis) or PE (pulmonary embolism)
  10. other injuries associated with current trauma to calculate Injury Severity Score

Patients will be treated with operative fixation of their fracture per standard of care. Within 24 hours of providing informed consent, we will obtain patient weight with a clinical scale or hospital bed equipped with clinical scale. We will obtain body composition using a validated handheld ultrasound device that reports fat mass, fat free mass, and % body fat (BodyMetrix, Intellimatrix, Brentwood, CA). Hand grip strength will be assessed with the patient's dominant hand, or non-dominant hand if unable to perform due to injury (hand dynamometer, Hausmann Industries, Northvale, New Jersey).

Following surgery, patients in the treatment group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. The control group will have standard nutrition provided per dietitian recommendation. Patients will have pain medication and postoperative therapies per standard of care.

The nutritional supplements will be consumed per manufacturer recommendations. Descriptions of nutritional supplementation are included below.

Juven is an oral nutritional supplement produced by Abbot Nutrition. It is not considered a drug and is not under FDA regulation. Juven has been studied in clinical trials and shown to decrease pressure ulcer occurrence, decrease muscle wasting, and increase collagen deposition in wound healing (10,11).

Juven is packaged as a powder containing 24g per pouch and is mixed with 8-10 fl oz water or juice for consumption. The recommended supplementation schedule is two servings daily in addition to balanced diet.

Nutrient data for Juven obtained from manufacturer's website 7/20/2017: https://abbottnutrition.com/juven Serving size: 24 g (1 packet) L-arginine 7g L-glutamine 7g Carbohydrate 7.9g Sugars 1g Calcium 200mg Calcium beta-hydroxy-beta-methylbutyrate 1.5g

After discharge from the hospital, we will communicate with patients by mobile phone messaging on a daily basis to confirm consumption of the investigative nutritional supplementation. We will also communicate with patients at 3 months, 6 months, 9 months, and 12 months after surgery to inquire about any complications or hospitalizations.

Following surgery, patients will be reevaluated in the orthopedic trauma clinic at routine intervals per standard of care (postoperative visits are typically scheduled at 2 weeks, 6 weeks, 6 months, and 1 year). Patients will be seen in clinic by orthopedic surgery trauma staff. All orthopedic trauma staff are included on the research team. As part of routine clinical follow up visit, research team will review the patient medical record, perform a focused history and physical exam and document any new hospital readmission, medical complication, surgical complication. Radiographs will be obtained per standard orthopedic care to assess fracture healing and no additional radiographs will be obtained for the purpose of this study.

At the patient's first postoperative clinic follow up, we will repeat measures of patient weight, body composition, and hand grip strength. These measures are expected to take less than 15 minutes at the time of their clinic appointment.

Subjects will also be asked to complete several questionnaires via RedCap at several times points during the study. The questionnaires will be completed either in clinic on a tablet or computer, or a secure link to the study will be emailed to subjects.

No data collection is planned after one year from the time of surgery.

02

Conditions studied

  • Trauma
  • Nutritional Deficiency
  • Wound Heal
03

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.

This study's enrollment of 400 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Michael C Willey is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of acute fracture of the upper extremity, pelvis, or lower extremity with plans for operative fixation

Exclusion criteria

Exclusion Criteria:

  • Patients with comorbidities excluding the use of proposed nutritional supplement (phenylketonuria, galactoseria)
  • Patients with major head trauma
  • Pregnant women

Dementia

Vulnerable populations (minors, prisoners)

Lack of decision making capacity

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Nutritional supplement group

    Subjects in this group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. Subjects will have pain medication and postoperative therapies per standard of care.

    Dietary Supplement: Juven

  • No intervention
    Standard nutrition group

    Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.

Interventions

  • Dietary supplementJuven

    Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations

06

What researchers measure

Primary outcomes

  1. Change in body composition

    Change in muscle mass

    Time frame: One year

Secondary outcomes

  1. Change in hand grip strength

    Change in hand grip strength as measured by hand held dynamometer

    Time frame: One year

  2. Number of participants with post-operative complications

    Medical and surgical complications following operative fracture fixation, validated patient reported outcome measures, radiographic measures of fracture healing, time spent in hospital, discharge status (home versus acute rehabilitation versus skilled nursing facility)

    Time frame: One year

07

Study locations

1 site
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03658278
Lead sponsor
Michael C Willey
Collaborators
Orthopaedic Trauma Association
Responsible party
Michael C Willey (Principal Investigator, University of Iowa) — Sponsor-investigator
First posted
Sep 5, 2018
Start date
Mar 15, 2018
Primary completion
Nov 13, 2019
Completion
Nov 13, 2019
Last update
Sep 21, 2023

Study contacts

Nathan Hendrickson, MD
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Juven

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