Nutritional Supplementation Effects on Rehabilitation Out... | NCT01798693

Studies
Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

NCT01798693

Sponsor

University of North Carolina, Chapel Hill

Status

Terminated

Last Update Posted

May 13, 2015Estimated

Enrollment

5Actual

Phase

Early Phase 1

Conditions

Rotator Cuff/Shoulder Structure and Function

Interventions

Placebo (maltodextrin)
Multi-nutrient Blend

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor subject compliance and inadequate recruitment

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Jan 18, 2013

First Submission Date that Met QC Criteria

Feb 21, 2013

First Posted Date

Feb 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2015

Last Update Posted Date

May 13, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abbie Smith-Ryan, PhD, Assistant Professor, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo (maltodextrin)	Placebo Comparator	Maltodextrin	Dietary Supplement: Placebo (maltodextrin)
Multi-Nutrient Blend	Active Comparator	Blend of vitamins, minerals, and amino acids, given twice daily	Dietary Supplement: Multi-nutrient Blend

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo (maltodextrin)	Dietary Supplement		Placebo (maltodextrin)
Multi-nutrient Blend

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in shoulder function, pain, strength and range of motion		Change from baseline to four, six, and twelve weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNC Orthopedics and Exercise and Sport Medicine		Chapel Hill	North Carolina		United States

Intervention Browse Module

MeSH Terms

ID	Term
C008315	maltodextrin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided