Rotator Cuff/Shoulder Structure and FunctionEarly Phase 1NCT01798693
Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology
A Early Phase 1 study testing Multi-nutrient Blend in people with Rotator Cuff/Shoulder Structure and Function, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Rotator Injury: Strength/range of Motion ASES, VAS Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff/Shoulder Structure and Function
- What is being tested?
- Multi-nutrient Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-65 years old
- Diagnosed with rotator cuff injury that will not be treated surgically
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
UNC Orthopedics and Exercise and Sport Medicine
Chapel Hill, North Carolina
About this study
Rotator Injury:
- Strength/range of Motion
- ASES, VAS
Read the 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.
- Being tested
- Placebo (maltodextrin), Multi-nutrient Blend
- Keywords
- Shoulder, Supplement, Amino Acids, Collagen, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (maltodextrin)Dietary supplement
Multi-nutrient BlendDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo (maltodextrin) | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo (maltodextrin) |
| Multi-Nutrient Blend | Active comparator | Blend of vitamins, minerals, and amino acids, given twice daily Receives: Dietary Supplement: Multi-nutrient Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shoulder function, pain, strength and range of motion
Measured: Change from baseline to four, six, and twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Poor subject compliance and inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff/Shoulder Structure and FunctionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798693
- Sponsor's protocol ID
- ORB-12-2374
- Status last verified
- May 2015
- First submitted
- 18 Jan 2013
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology
- ClinicalTrials.gov ID
- NCT01798693
- Acronym / sponsor ID
- ORB-12-2374
- Keywords
- Shoulder, Supplement, Amino Acids, Collagen, Standard of Care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor subject compliance and inadequate recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (maltodextrin) | Placebo comparator | Dietary Supplement: Placebo (maltodextrin)Maltodextrin |
| Multi-Nutrient Blend | Active comparator | Dietary Supplement: Multi-nutrient BlendBlend of vitamins, minerals, and amino acids, given twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18-65 years old
- Diagnosed with rotator cuff injury that will not be treated surgically
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (maltodextrin) | Dietary supplement | Placebo (maltodextrin) |
| Multi-nutrient Blend | Dietary supplement | Multi-Nutrient Blend |
Primary outcome
Change in shoulder function, pain, strength and range of motion
Time frame: Change from baseline to four, six, and twelve weeks
Results and safety
The study was stopped early (reason given: Poor subject compliance and inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Multi-nutrient Blend in people with Rotator Cuff/Shoulder Structure and Function, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor subject compliance and inadequate recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in shoulder function, pain, strength and range of motion (time frame: Change from baseline to four, six, and twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.