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Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status and phase

Terminated
Early Phase 1

Conditions

Rotator Cuff/Shoulder Structure and Function

Treatments

Dietary Supplement: Multi-nutrient Blend
Dietary Supplement: Placebo (maltodextrin)

Study type

Interventional

Funder types

Other

Identifiers

NCT01798693
ORB-12-2374

Details and patient eligibility

About

Rotator Injury:

  • Strength/range of Motion
  • ASES, VAS

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

5 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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