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Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Status
Terminated
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01798693
Enrollment
5
Registered
2013-02-26
Start date
2013-08-31
Completion date
2014-08-31
Last updated
2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff/Shoulder Structure and Function

Keywords

Shoulder, Supplement, Amino Acids, Collagen, Standard of Care

Brief summary

Rotator Injury: * Strength/range of Motion * ASES, VAS

Detailed description

The addition of a nutritional therapy to a standardized physical therapy program, may expedite recovery from shoulder injury. An attractive feature of this approach is the development of an efficacious adjunct therapy that is economically superior to traditional therapy modalities and logistically feasible.

Interventions

DIETARY_SUPPLEMENTPlacebo (maltodextrin)
DIETARY_SUPPLEMENTMulti-nutrient Blend

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Between 18-65 years old * Diagnosed with rotator cuff injury that will not be treated surgically

Exclusion criteria

* Have received a previous injection therapy (platelet-rich plasma or corticosteroid injection) within previous 6 months * Have used the following supplements in the previous 2 weeks: Vitamin C or D, or protein supplements * Have poorly controlled type I or type II diabetes (HgB A1C \> 9.5%) or renal insufficiency (GFR \< 60 ml/min). * Have an inability to participate in rehabilitation exercises. * Are diagnosed with arthritis, rheumatoid arthritis, or any other autoimmune or rheumatologic disease * Have musculoskeletal pathology in a neighboring joint or structure * Have an allergy to any component of the nutritional supplement * Are consuming warfarin

Design outcomes

Primary

MeasureTime frame
Change in shoulder function, pain, strength and range of motionChange from baseline to four, six, and twelve weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026