Rheumatoid ArthritisNCT01767844
Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients?
A study testing Creatine in people with Rheumatoid Arthritis, run by Bangor University at 1 site in United Kingdom.
Trial summary
Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Feb 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfil the American Rheumatism Association 1987 revised criteria for the diagnosis of RA
- be functional class I or II
- be age 18 years or over
Who cannot join
- be cognitively impaired; (b) have any other cachectic diseases and any condition preventing safe participation in the study
- have a glomerular filtration rate above 60mL/min/1.73m2, assessed from medical records, and no other evidence of kidney damage
- be taking drugs or other nutritional supplements known to increase muscle mass
- be participating in regular and intense physical training program be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot Trial
Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly.
50 participants will be given a food supplement to take for 12 weeks; this supplement will either be creatine or a placebo (a regular fruit flavoured powder that has no benefits).
Over 12 weeks, body fat and muscle size (body composition), physical function, and fitness (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will be tested. In addition, quality of life questionnaires will be completed, disease activity will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be obtained, from those who volunteer to provide them, at baseline and post-treatment.
Read the detailed description
Background and aims
Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. This reduces their ability to complete daily tasks and increases disability, as well as increasing the risk to infection and other illness.
Exercise is most effective for increasing muscle size and strength, but it is time consuming, expensive and hard work, meaning uptake is poor. So, widely acceptable alternatives are required.
The study aims to test a food supplement called creatine. Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise.
The creatine will be provided as a fruit flavoured powder that participants will mix with water and drink, much like a fruit squash. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly
Who are the participants?
50 patients with who have stable and controlled RA, are over age 18, with no known kidney problems.
What does the study involve?
50 participants will be given a food supplement to take for 12 weeks; this supplement will either be creatine or a placebo (a regular fruit flavoured powder that has no benefits). Participants will be randomly allocated to a group and will not be told which supplement they are taking until the end of the trial. The supplement will be taken as a drink 4 times a day for the first 5 days, and then once a day for the remainder of the 12 weeks.
Participants will be asked to attend Bangor University 4 times to have a series of tests done.
The four testing points are:
- before they start supplementation
- after the 5 days
- at completion of the 12-weeks of supplementation
- 12 weeks after completion of the 12 week supplementation period.
At all four testing points (1-4) body fat and muscle size (body composition), physical function, and fitness (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will be tested. In addition, quality of life questionnaires will be completed, disease activity will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be obtained, from those who volunteer to provide them, at baseline and post-treatment (test points 1 and 3).
Body fat and muscle size (body composition) will be assessed using type of X-ray called 'dual-entry X-ray absorptiometry' (DXA) scans and by looking at body water levels. DXA allows the research team to estimate the amount of lean tissue (muscle) and fat that is in the body. The scan is completely painless.
Physical function will be assessed using the following tests:
- strength tests of the knee muscles and hand-grip
- the Up-and-Go Test (UG) - For the UG, participants are required rise from a seated position on a fixed chair, walk forward to a cone placed 8ft (2.44 m) away, and return to the chair and a seated position.
- the sit-to-stand in 30 sec test (SST-30) - For the SST-30 participants will rise from the same seated position as during the UG as many times as possible in 30 s whilst keeping their arms folded across the chest.
- 50-ft walk test - During the 50-ft walk test, time taken to complete the walk along a straight line marked by cones is recorded
- To assess fitness participants will complete a step test. During the test participants are required to step up and down a 10-inch step at a tempo controlled by a metronome for three x three-minute stages or until the target heart rate (65% of predicted maximum heart rate) is achieved. This test will normally last 3 minutes
What are the potential risks and benefits?
Risks - A disadvantage of taking part is the time commitment required to participate in the study. Whilst taking the supplement drink will be quick and simple, there are 4 testing sessions which may 2 hours in which participants must attend at Bangor University. Any travel expenses participants incur for participating in this study will be paid for.
Creatine supplementation will cause some weight gain; in the short-term this is due to water retention by the muscle and in the long-term this is due to an increase in muscle size. Previous research, including research with RA patients, has found no adverse side effects that can be linked to the creatine supplementation. There are anecdotal reports of creatine supplementation causing muscle cramps, stomach and heart problems; however no evidence has ever linked these directly to the creatine itself.
There is also a slight possibility that the muscle biopsy site (where the muscle is taken) could bruise and be sore but this is quite rare and in fact most people report only a short term slight ache after the biopsy.
There is also an exposure to radiation (emission of energy) from the DXA scan, though this is only a small amount. However, because of this radiation pregnant women are not allowed to part in the study.
Benefits - Taking creatine supplements will increase muscle strength and improve physical function and quality of life.
Participants will receive creatine supplementation regardless of which group they are initially put into. Participants will also be informed about their fitness levels and will receive advice on how to improve these.
The standard DXA can inform the investigaters of a disease in the bone that can increase the risk of fractures (osteoporosis) that patients might not know they had.
Who is running the study and how long will it last? The study will commence in January 2012 and is being undertaken by the School of Sport, Health and Exericse Sciences (SSHES) at Bangor University, Wales, in association with the Rheumatology department at Ysbyty Gwynedd Hospital, Bangor.
Who is funding the study? The study is being funded by Betsi Cadwalader University Health Board. The study is expected to finish within an 18 month time frame, with recruiting open for a year or until 50 patients have been found.
Who is the main contact? Prof Andrew Lemmey a.lemmey@bangor.ac.uk Dr Tom O'Brien thomas.obrien@bangor.ac.uk Thomas Wilkinson, thomas.wilkinson@bangor.ac.uk
- Conditions
- Rheumatoid Arthritis
- Being tested
- Creatine, Placebo
- Keywords
- Rheumatoid Arthritis, Arthritis, Rheumatology, Creatine
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Also called Creatine Monohydrate (MyProtein.uk), SN: 5055534301999 BB: 09/2014
Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise.
PlaceboDietary supplement
Also called Placebo Comparator: Fruit powder drink - A regular fruit flavoured powder that has no benefits., Manufactured by Foster Clarks Ltd (www.fosterclark.com)
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise. Receives: Dietary Supplement: Creatine |
| Fruit powder drink | Placebo comparator | A regular fruit flavoured powder that has no benefits Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 'Objectively assessed whole body function'
Physical function will be assessed using the following tests:
- strength tests of the knee muscles and hand-grip
- the Up-and-Go Test (UG) - For the UG, participants are required rise from a seated position on a fixed chair, walk forward to a cone placed 8ft (2.44 m) away, and return to the chair and a seated position.
- the sit-to-stand in 30 sec test (SST-30) - For the SST-30 participants will rise from the same seated position as during the UG as many times as possible in 30 s whilst keeping their arms folded across the chest.
- 50-ft walk test - During the 50-ft walk test, time taken to complete the walk along a straight line marked by cones is recorded
- To assess fitness participants will complete the Siconolfi step test.
Measured: Measured at Baseline, Day 6, Week 12, Week 24
Secondary outcomes (1)
Change in body composition
Body fat and muscle size (body composition) will be assessed using type of X-ray called 'dual-entry X-ray absorptiometry' (DXA) scans and by looking at body water levels. DXA allows the research team to estimate the amount of lean tissue (muscle) and fat that is in the body. The scan is completely painless.
Measured: Baseline, Day 6, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas James Wilkinson, Bangor University
- Investigators
- Andrew B Lemmey, Prof., Principal investigator, Bangor UniversityThomas O'Brien, Dr, Principal investigator, Bangor UniversityThomas J Wilkinson, Principal investigator, Bangor Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767844
- Sponsor's protocol ID
- 12/WA/0320
- Other IDs
- 110850
- Status last verified
- Dec 2014
- First submitted
- 8 Jan 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Willer B, Stucki G, Hoppeler H, Bruhlmann P, Krahenbuhl S. Effects of creatine supplementation on muscle weakness in patients with rheumatoid arthritis. Rheumatology (Oxford). 2000 Mar;39(3):293-8. doi: 10.1093/rheumatology/39.3.293.
PubMed 10788538Lemmey AB, Jones J, Maddison PJ. Rheumatoid cachexia: what is it and why is it important? J Rheumatol. 2011 Sep;38(9):2074; author reply 2075. doi: 10.3899/jrheum.110308. No abstract available.
PubMed 21885521Lemmey AB, Williams SL, Marcora SM, Jones J, Maddison PJ. Are the benefits of a high-intensity progressive resistance training program sustained in rheumatoid arthritis patients? A 3-year followup study. Arthritis Care Res (Hoboken). 2012 Jan;64(1):71-5. doi: 10.1002/acr.20523.
PubMed 21671413Lemmey AB, Marcora SM, Chester K, Wilson S, Casanova F, Maddison PJ. Effects of high-intensity resistance training in patients with rheumatoid arthritis: a randomized controlled trial. Arthritis Rheum. 2009 Dec 15;61(12):1726-34. doi: 10.1002/art.24891.
PubMed 19950325Marcora S, Lemmey A, Maddison P. Dietary treatment of rheumatoid cachexia with beta-hydroxy-beta-methylbutyrate, glutamine and arginine: a randomised controlled trial. Clin Nutr. 2005 Jun;24(3):442-54. doi: 10.1016/j.clnu.2005.01.006. Epub 2005 Apr 21.
PubMed 15896432Cooney JK, Law RJ, Matschke V, Lemmey AB, Moore JP, Ahmad Y, Jones JG, Maddison P, Thom JM. Benefits of exercise in rheumatoid arthritis. J Aging Res. 2011 Feb 13;2011:681640. doi: 10.4061/2011/681640.
PubMed 21403833Nissen SL, Sharp RL. Effect of dietary supplements on lean mass and strength gains with resistance exercise: a meta-analysis. J Appl Physiol (1985). 2003 Feb;94(2):651-9. doi: 10.1152/japplphysiol.00755.2002. Epub 2002 Oct 25.
PubMed 12433852
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT01767844
- Acronym / sponsor ID
- 12/WA/0320
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Arthritis, Rheumatology, Creatine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 14 Jan 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.
Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly.
50 participants will be given a food supplement to take for 12 weeks; this supplement will either be creatine or a placebo (a regular fruit flavoured powder that has no benefits).
Over 12 weeks, body fat and muscle size (body composition), physical function, and fitness (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will be tested. In addition, quality of life questionnaires will be completed, disease activity will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be obtained, from those who volunteer to provide them, at baseline and post-treatment.
Detailed description
Background and aims
Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. This reduces their ability to complete daily tasks and increases disability, as well as increasing the risk to infection and other illness.
Exercise is most effective for increasing muscle size and strength, but it is time consuming, expensive and hard work, meaning uptake is poor. So, widely acceptable alternatives are required.
The study aims to test a food supplement called creatine. Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise.
The creatine will be provided as a fruit flavoured powder that participants will mix with water and drink, much like a fruit squash. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly
Who are the participants?
50 patients with who have stable and controlled RA, are over age 18, with no known kidney problems.
What does the study involve?
50 participants will be given a food supplement to take for 12 weeks; this supplement will either be creatine or a placebo (a regular fruit flavoured powder that has no benefits). Participants will be randomly allocated to a group and will not be told which supplement they are taking until the end of the trial. The supplement will be taken as a drink 4 times a day for the first 5 days, and then once a day for the remainder of the 12 weeks.
Participants will be asked to attend Bangor University 4 times to have a series of tests done.
The four testing points are:
- before they start supplementation
- after the 5 days
- at completion of the 12-weeks of supplementation
- 12 weeks after completion of the 12 week supplementation period.
At all four testing points (1-4) body fat and muscle size (body composition), physical function, and fitness (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will be tested. In addition, quality of life questionnaires will be completed, disease activity will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be obtained, from those who volunteer to provide them, at baseline and post-treatment (test points 1 and 3).
Body fat and muscle size (body composition) will be assessed using type of X-ray called 'dual-entry X-ray absorptiometry' (DXA) scans and by looking at body water levels. DXA allows the research team to estimate the amount of lean tissue (muscle) and fat that is in the body. The scan is completely painless.
Physical function will be assessed using the following tests:
- strength tests of the knee muscles and hand-grip
- the Up-and-Go Test (UG) - For the UG, participants are required rise from a seated position on a fixed chair, walk forward to a cone placed 8ft (2.44 m) away, and return to the chair and a seated position.
- the sit-to-stand in 30 sec test (SST-30) - For the SST-30 participants will rise from the same seated position as during the UG as many times as possible in 30 s whilst keeping their arms folded across the chest.
- 50-ft walk test - During the 50-ft walk test, time taken to complete the walk along a straight line marked by cones is recorded
- To assess fitness participants will complete a step test. During the test participants are required to step up and down a 10-inch step at a tempo controlled by a metronome for three x three-minute stages or until the target heart rate (65% of predicted maximum heart rate) is achieved. This test will normally last 3 minutes
What are the potential risks and benefits?
Risks - A disadvantage of taking part is the time commitment required to participate in the study. Whilst taking the supplement drink will be quick and simple, there are 4 testing sessions which may 2 hours in which participants must attend at Bangor University. Any travel expenses participants incur for participating in this study will be paid for.
Creatine supplementation will cause some weight gain; in the short-term this is due to water retention by the muscle and in the long-term this is due to an increase in muscle size. Previous research, including research with RA patients, has found no adverse side effects that can be linked to the creatine supplementation. There are anecdotal reports of creatine supplementation causing muscle cramps, stomach and heart problems; however no evidence has ever linked these directly to the creatine itself.
There is also a slight possibility that the muscle biopsy site (where the muscle is taken) could bruise and be sore but this is quite rare and in fact most people report only a short term slight ache after the biopsy.
There is also an exposure to radiation (emission of energy) from the DXA scan, though this is only a small amount. However, because of this radiation pregnant women are not allowed to part in the study.
Benefits - Taking creatine supplements will increase muscle strength and improve physical function and quality of life.
Participants will receive creatine supplementation regardless of which group they are initially put into. Participants will also be informed about their fitness levels and will receive advice on how to improve these.
The standard DXA can inform the investigaters of a disease in the bone that can increase the risk of fractures (osteoporosis) that patients might not know they had.
Who is running the study and how long will it last? The study will commence in January 2012 and is being undertaken by the School of Sport, Health and Exericse Sciences (SSHES) at Bangor University, Wales, in association with the Rheumatology department at Ysbyty Gwynedd Hospital, Bangor.
Who is funding the study? The study is being funded by Betsi Cadwalader University Health Board. The study is expected to finish within an 18 month time frame, with recruiting open for a year or until 50 patients have been found.
Who is the main contact? Prof Andrew Lemmey a.lemmey@bangor.ac.uk Dr Tom O'Brien thomas.obrien@bangor.ac.uk Thomas Wilkinson, thomas.wilkinson@bangor.ac.uk
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine | Experimental | Dietary Supplement: CreatineCreatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise. |
| Fruit powder drink | Placebo comparator | Dietary Supplement: PlaceboA regular fruit flavoured powder that has no benefits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fulfil the American Rheumatism Association 1987 revised criteria for the diagnosis of RA
- be functional class I or II
- be age 18 years or over
Key exclusion criteria (4 listed)
- be cognitively impaired; (b) have any other cachectic diseases and any condition preventing safe participation in the study
- have a glomerular filtration rate above 60mL/min/1.73m2, assessed from medical records, and no other evidence of kidney damage
- be taking drugs or other nutritional supplements known to increase muscle mass
- be participating in regular and intense physical training program be pregnant
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 |
|---|---|---|
| CreatineAlso: Creatine Monohydrate (MyProtein.uk), SN: 5055534301999 BB: 09/2014Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise. | Dietary supplement | Creatine |
| PlaceboAlso: Placebo Comparator: Fruit powder drink - A regular fruit flavoured powder that has no benefits., Manufactured by Foster Clarks Ltd (www.fosterclark.com) | Dietary supplement | Fruit powder drink |
Primary outcome
Change in 'Objectively assessed whole body function'
Time frame: Measured at Baseline, Day 6, Week 12, Week 24
Physical function will be assessed using the following tests: 1. strength tests of the knee muscles and hand-grip 2. the Up-and-Go Test (UG) - For the UG, participants are required rise from a seated position on a fixed chair, walk forward to a cone placed 8ft (2.44 m) away, and return to the chair and a seated position. 3. the sit-to-stand in 30 sec test (SST-30) - For the SST-30 participants will rise from the same seated position as during the UG as many times as possible in 30 s whilst keeping their arms folded across the chest. 4. 50-ft walk test - During the 50-ft walk test, time taken to complete the walk along a straight line marked by cones is recorded 5. To assess fitness participants will complete the Siconolfi step test.
1 secondary outcome
Change in body composition
Time frame: Baseline, Day 6, Week 12, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 10788538Willer B, Stucki G, Hoppeler H, Bruhlmann P, Krahenbuhl S. Effects of creatine supplementation on muscle weakness in patients with rheumatoid arthritis. Rheumatology (Oxford). 2000 Mar;39(3):293-8. doi: 10.1093/rheumatology/39.3.293.
- Background: PubMed 21885521Lemmey AB, Jones J, Maddison PJ. Rheumatoid cachexia: what is it and why is it important? J Rheumatol. 2011 Sep;38(9):2074; author reply 2075. doi: 10.3899/jrheum.110308. No abstract available.
- Background: PubMed 21671413Lemmey AB, Williams SL, Marcora SM, Jones J, Maddison PJ. Are the benefits of a high-intensity progressive resistance training program sustained in rheumatoid arthritis patients? A 3-year followup study. Arthritis Care Res (Hoboken). 2012 Jan;64(1):71-5. doi: 10.1002/acr.20523.
- Background: PubMed 19950325Lemmey AB, Marcora SM, Chester K, Wilson S, Casanova F, Maddison PJ. Effects of high-intensity resistance training in patients with rheumatoid arthritis: a randomized controlled trial. Arthritis Rheum. 2009 Dec 15;61(12):1726-34. doi: 10.1002/art.24891.
- Background: PubMed 15896432Marcora S, Lemmey A, Maddison P. Dietary treatment of rheumatoid cachexia with beta-hydroxy-beta-methylbutyrate, glutamine and arginine: a randomised controlled trial. Clin Nutr. 2005 Jun;24(3):442-54. doi: 10.1016/j.clnu.2005.01.006. Epub 2005 Apr 21.
- Background: PubMed 21403833Cooney JK, Law RJ, Matschke V, Lemmey AB, Moore JP, Ahmad Y, Jones JG, Maddison P, Thom JM. Benefits of exercise in rheumatoid arthritis. J Aging Res. 2011 Feb 13;2011:681640. doi: 10.4061/2011/681640.
- Background: PubMed 12433852Nissen SL, Sharp RL. Effect of dietary supplements on lean mass and strength gains with resistance exercise: a meta-analysis. J Appl Physiol (1985). 2003 Feb;94(2):651-9. doi: 10.1152/japplphysiol.00755.2002. Epub 2002 Oct 25.
Related trials for Rheumatoid Arthritis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Andrew B Lemmey, Prof. principal investigator
Bangor University
Thomas O'Brien, Dr principal investigator
Bangor University
Thomas J Wilkinson principal investigator
Bangor Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Rheumatoid Arthritis, run by Bangor University at 1 site in United Kingdom.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Dec 2014. 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 Kingdom. 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.
Are results available for this study?
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 'Objectively assessed whole body function' (time frame: Measured at Baseline, Day 6, Week 12, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767844, which also lists 7 linked publications.
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 3 Dec 2014.