Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

NCT ID: NCT01798693

Last Updated: 2015-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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Rotator Injury:

* Strength/range of Motion
* ASES, VAS

Detailed Description

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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.

Conditions

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Rotator Cuff/Shoulder Structure and Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo (maltodextrin)

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo (maltodextrin)

Intervention Type DIETARY_SUPPLEMENT

Multi-Nutrient Blend

Blend of vitamins, minerals, and amino acids, given twice daily

Group Type ACTIVE_COMPARATOR

Multi-nutrient Blend

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo (maltodextrin)

Intervention Type DIETARY_SUPPLEMENT

Multi-nutrient Blend

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Abbie Smith-Ryan, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UNC Orthopedics and Exercise and Sport Medicine

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ORB-12-2374

Identifier Type: -

Identifier Source: org_study_id

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