Patellar TendinopathyJumpfoodNCT05407194
Effect of Collagen/Vitamin C in Jumper's Knee; a RCT
A study testing Collagen + vitamin C in people with Patellar Tendinopathy, run by Gelderse Vallei Hospital at 1 site in Netherlands.
Trial summary
Patellar tendinopathy (PT) is a tendon overuse injury with high prevalence rates in elite and recreational athletes. PT sometimes results in a prolonged absence from sport participation, hampering individuals to achieve their desired performance levels and to benefit from the health related effects of sports… Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- Collagen + vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2023to 1 May 2026
- 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 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16 - 40 years old (the chosen age range will minimize chances of other conditions causing anterior knee pain such as osteoarthritis among patients above 40 years and osteochondrotic diseases like Sinding-Larsen-Johansson syndrome and Osgood-Schlatter disease among patients below the age of 16).
- History of focal knee pain in patellar tendon or its patellar or tibial insertion in association with training and/or competition.
- Current symptom duration of at least 12 weeks.
- Sports participation at least once a week for at least one year.
- Palpation tenderness to the corresponding painful area on the patellar tendon.
- Focal patellar tendon pain during patellar tendon loading with a pain provocation test (single leg decline squat and/or single leg jump squat)
- Victorian Institute of Sports Assessment (VISA-P) score < 80 out of 100 points.
- Willingness to take (non-vegetarian) nutritional supplements.
Who cannot join
- Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout or rheumatoid arthritis) or familial hypercholesterolaemia.
- Daily use of drugs with a putative effect on the patellar tendon in the preceding year (e.g. fluoroquinolones and statins)
- Knee surgery without a full completion of the rehabilitation program in the history of the index knee
- Previous patellar tendon rupture of the index knee
- Local injection therapy with corticosteroids, other drugs, blood, platelet rich plasma or stem cells in the preceding 12 months
- Acute knee injuries, including patellar tendon injuries with an acute onset
Show all 14Show fewer
- Inability to perform the PTLE program
- Participation in other concomitant treatment programs
- Signs or symptoms of other coexisting knee pathology on physical examination (such as patellofemoral pain syndrome, joint effusion and joint line tenderness) or additional diagnostics when found necessary by the sports physician (Chondral lesion of the patella or trochlea on MRI or prepatellar bursitis on US).
- Already using collagen supplementation
- Giving blood donation in a period of two months prior to each test day
- Being pregnant or wish to become pregnant in the upcoming year
- Abuse of hard drugs
- An alcohol consumption >21 units/week (men) or >14 units/week (women)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Gelderse Vallei Hospital
Ede, Gelderland, 6716RP
Rieneke Terink, Dr, 0031611172845, rterink@zgv.nl
Johannes Zwerver, Prof, 0031318434350, jzwerver@zgv.nl
About this study
Official title: Additional Effect of Collagen/Vitamin C in Exercise Treatment for Patellar Tendinopathy (Jumper's Knee); a Randomized Controlled Trial
Patellar tendinopathy (PT) is a tendon overuse injury with high prevalence rates in elite and recreational athletes. PT sometimes results in a prolonged absence from sport participation, hampering individuals to achieve their desired performance levels and to benefit from the health related effects of sports participation. Many treatment options are used but management of PT remains challenging. Current treatment involves progressive education, load management and tendon loading exercises (PTLE). Recent studies have shown that nutrition can positively affect collagen synthesis in musculoskeletal tissues. A study showed that supplementing 15g of gelatine combined with 50mg of Vitamin C, 1 hour before loading exercises, resulted in an increase in whole body collagen synthesis and increased mechanics and collagen content of human engineered ligaments. However the effectiveness of oral supplementation of hydrolysed collagen in combination with vitamin C in athletes with PT has not been studied in a randomized controlled trial yet.
Objective: The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 12, 24 and 52 weeks for athletes with PT. The secondary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on other clinical outcome parameters, functional tests and tendon structure after 12 and 24 weeks for athletes with PT.
Read the detailed description
Rationale: Patellar tendinopathy (PT) is a tendon overuse injury with high prevalence rates in elite and recreational athletes. PT sometimes results in a prolonged absence from sport participation, hampering individuals to achieve their desired performance levels and to benefit from the health related effects of sports participation. Many treatment options are used but management of PT remains challenging. Current treatment involves progressive education, load management and tendon loading exercises (PTLE). Recent studies have shown that nutrition can positively affect collagen synthesis in musculoskeletal tissues. A study showed that supplementing 15g of gelatine combined with 50mg of Vitamin C, 1 hour before loading exercises, resulted in an increase in whole body collagen synthesis and increased mechanics and collagen content of human engineered ligaments. However the effectiveness of oral supplementation of hydrolysed collagen in combination with vitamin C in athletes with PT has not been studied in a randomized controlled trial yet.
Objective: The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 12, 24 and 52 weeks for athletes with PT. The secondary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on other clinical outcome parameters, functional tests and tendon structure after 12 and 24 weeks for athletes with PT.
Study design: The JUMPFOOD-study is a double blinded, 2-armed randomized placebo controlled trial which investigates the effectiveness of oral supplementation of hydrolysed collagen and vitamin C combined with progressive tendon loading exercise compared to only progressive tendon loading exercises in athletes with PT.
Study population: Recreational, competitive and professional male and female athletes from different kinds of sports will be included. Inclusion criteria: age 16-40 years old; history of focal knee pain for at least 12 weeks localized in the region of the patellar tendon in association with training and competition; playing sports for at least once a week for at least one year; palpation tenderness to the corresponding painful area on the patellar tendon; Victorian Institute of Sports Assessment - Patella (VISA-P) score < 80 out of 100 points.
Intervention: The intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C, in comparison to a placebo supplement consisting of maltodextrin. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement.
Main study parameters/endpoints: The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up. Secondary outcomes will include: Pain during functional tests, advanced imaging methods and tendon structure and stiffness measurements (MRI, ultrasound, UTC, Myoton), blood levels of amino acids and inflammatory markers measured in blood, and dietary habits, that will all be measured at baseline, at 12 weeks and at 24 weeks of follow-up. In addition, data on the compliance with the exercise program and supplement intake, training and competition load will be collected weekly using an online questionnaire.
- Conditions
- Patellar Tendinopathy
- Being tested
- Collagen + vitamin C
- Keywords
- collagen, progressive tendon loading therapy, gelatin, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen + vitamin CDietary supplement
Participants take the supplement (or placebo) every day for 24 weeks. On three days per week they perform tendon loading exercises.
| Study group | Role | What they receive |
|---|---|---|
| Supplement + progressive tendon loading therapy | Experimental | The intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C, in comparison to a placebo supplement consisting of maltodextrin. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement. Receives: Dietary Supplement: Collagen + vitamin C |
| Placebo + progressive tendon loading therapy | Placebo comparator | The placebo consists of maltodextrin. In comparison the intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement. Receives: Dietary Supplement: Collagen + vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Measured: after 6 weeks follow-up
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Measured: after 12 weeks follow-up
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Measured: after 18 weeks follow-up
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Measured: after 24 weeks follow-up
VISA-P Score
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
Measured: after 52 weeks follow-up
Secondary outcomes (13)
Pain during functional tests
During several functional tests, pain will be measured on a visual analogue scale, with 0 meaning no pain and 10 meaning unbearable pain, at baseline, 12 weeks and 24 weeks of follow-up.
Measured: after 12 weeks follow-up
Pain during functional tests
During several functional tests, pain will be measured on a visual analogue scale, with 0 meaning no pain and 10 meaning unbearable pain, at baseline, 12 weeks and 24 weeks of follow-up.
Measured: after 24 weeks follow-up
Imaging methods
Several imaging methods will be performed to identify the physiological parameter tendon structure shown in percentages healthy and damaged cells, at baseline, 12 weeks and 24 weeks of follow-up.
Measured: after 12 weeks follow-up
Imaging methods
Several imaging methods will be performed to identify the physiological parameter tendon structure shown in percentages healthy and damaged cells, at baseline, 12 weeks and 24 weeks of follow-up.
Measured: after 24 weeks follow-up
Stiffness measurement
The physiological parameter stiffness of the tendon will be measured in N/m, at baseline, 12 weeks and 24 weeks of follow-up.
Measured: after 12 weeks follow-up
Stiffness measurement
The physiological parameter stiffness of the tendon will be measured in N/m, at baseline, 12 weeks and 24 weeks of follow-up.
Measured: after 24 weeks follow-up
Blood levels of amino acids
Concentration of amino acids in blood will be measured at baseline, 12 weeks and after 24 weeks of follow-up
Measured: after 12 weeks follow-up
Blood levels of amino acids
Concentration of amino acids in blood will be measured at baseline, 12 weeks and after 24 weeks of follow-up
Measured: after 24 weeks follow-up
Blood levels of inflammatory markers
Concentration in blood of the inflammatory markers BSE and CRP will be measured at baseline, 12 weeks and after 24 weeks of follow-up
Measured: after 12 weeks follow-up
Blood levels of inflammatory markers
Concentration in blood of the inflammatory markers BSE and CRP will be measured at baseline, 12 weeks and after 24 weeks of follow-up
Measured: after 24 weeks follow-up
Dietary habits
Dietary habits (nutritional intake) will be measured at the start and end of the intervention period using a diary.
Measured: baseline
Dietary habits
Dietary habits (nutritional intake) will be measured at the start and end of the intervention period using a diary.
Measured: after 24 weeks
Compliance
Data on the compliance with the exercise program and supplement intake, but also on training and competition load will be collected weekly using an online questionnaire
Measured: Weekly during the intervention, up to 24 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Apr 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinopathyStudies 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
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gelderse Vallei Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rieneke Terink, Gelderse Vallei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407194
- Sponsor's protocol ID
- NL79100.081.21
- Acronym
- Jumpfood
- Status last verified
- Sep 2024
- First submitted
- 8 Jan 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient data, not able to share
Publications
van Dam L, Terink R, Mensink M, de Vos RJ, Zwerver J. The JUMPFOOD study: additional effect of hydrolyzed collagen and vitamin C to exercise treatment for patellar tendinopathy (jumper's knee) in athletes-study protocol for a double-blind randomized controlled trial. Trials. 2023 Nov 28;24(1):768. doi: 10.1186/s13063-023-07783-2.
PubMed 38017500
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effect of Collagen/Vitamin C in Exercise Treatment for Patellar Tendinopathy (Jumper's Knee); a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05407194
- Acronym / sponsor ID
- Jumpfood / NL79100.081.21
- Conditions
- Patellar Tendinopathy
- Keywords
- collagen, progressive tendon loading therapy, gelatin, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Gelderse Vallei HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 7 Jun 2022 (actual)
- 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.
Patellar tendinopathy (PT) is a tendon overuse injury with high prevalence rates in elite and recreational athletes. PT sometimes results in a prolonged absence from sport participation, hampering individuals to achieve their desired performance levels and to benefit from the health related effects of sports participation. Many treatment options are used but management of PT remains challenging. Current treatment involves progressive education, load management and tendon loading exercises (PTLE). Recent studies have shown that nutrition can positively affect collagen synthesis in musculoskeletal tissues. A study showed that supplementing 15g of gelatine combined with 50mg of Vitamin C, 1 hour before loading exercises, resulted in an increase in whole body collagen synthesis and increased mechanics and collagen content of human engineered ligaments. However the effectiveness of oral supplementation of hydrolysed collagen in combination with vitamin C in athletes with PT has not been studied in a randomized controlled trial yet.
Objective: The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 12, 24 and 52 weeks for athletes with PT. The secondary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on other clinical outcome parameters, functional tests and tendon structure after 12 and 24 weeks for athletes with PT.
Detailed description
Rationale: Patellar tendinopathy (PT) is a tendon overuse injury with high prevalence rates in elite and recreational athletes. PT sometimes results in a prolonged absence from sport participation, hampering individuals to achieve their desired performance levels and to benefit from the health related effects of sports participation. Many treatment options are used but management of PT remains challenging. Current treatment involves progressive education, load management and tendon loading exercises (PTLE). Recent studies have shown that nutrition can positively affect collagen synthesis in musculoskeletal tissues. A study showed that supplementing 15g of gelatine combined with 50mg of Vitamin C, 1 hour before loading exercises, resulted in an increase in whole body collagen synthesis and increased mechanics and collagen content of human engineered ligaments. However the effectiveness of oral supplementation of hydrolysed collagen in combination with vitamin C in athletes with PT has not been studied in a randomized controlled trial yet.
Objective: The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 12, 24 and 52 weeks for athletes with PT. The secondary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on other clinical outcome parameters, functional tests and tendon structure after 12 and 24 weeks for athletes with PT.
Study design: The JUMPFOOD-study is a double blinded, 2-armed randomized placebo controlled trial which investigates the effectiveness of oral supplementation of hydrolysed collagen and vitamin C combined with progressive tendon loading exercise compared to only progressive tendon loading exercises in athletes with PT.
Study population: Recreational, competitive and professional male and female athletes from different kinds of sports will be included. Inclusion criteria: age 16-40 years old; history of focal knee pain for at least 12 weeks localized in the region of the patellar tendon in association with training and competition; playing sports for at least once a week for at least one year; palpation tenderness to the corresponding painful area on the patellar tendon; Victorian Institute of Sports Assessment - Patella (VISA-P) score < 80 out of 100 points.
Intervention: The intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C, in comparison to a placebo supplement consisting of maltodextrin. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement.
Main study parameters/endpoints: The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up. Secondary outcomes will include: Pain during functional tests, advanced imaging methods and tendon structure and stiffness measurements (MRI, ultrasound, UTC, Myoton), blood levels of amino acids and inflammatory markers measured in blood, and dietary habits, that will all be measured at baseline, at 12 weeks and at 24 weeks of follow-up. In addition, data on the compliance with the exercise program and supplement intake, training and competition load will be collected weekly using an online questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Supplement + progressive tendon loading therapy | Experimental | Dietary Supplement: Collagen + vitamin CThe intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C, in comparison to a placebo supplement consisting of maltodextrin. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement. |
| Placebo + progressive tendon loading therapy | Placebo comparator | Dietary Supplement: Collagen + vitamin CThe placebo consists of maltodextrin. In comparison the intervention consists of a nutritional supplement with 10g hydrolysed collagen and 40 mg vitamin C. All participants in both groups will receive education, load management advices and a criteria-based PTLE consisting of 4 stages within the limits of pain during 24-weeks. This (training) intervention has recently been proven to be superior to eccentric training. Participants will be randomly assigned to receive either the nutritional supplement collagen/vitamin C (intervention) or a placebo supplement. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 16 - 40 years old (the chosen age range will minimize chances of other conditions causing anterior knee pain such as osteoarthritis among patients above 40 years and osteochondrotic diseases like Sinding-Larsen-Johansson syndrome and Osgood-Schlatter disease among patients below the age of 16).
- History of focal knee pain in patellar tendon or its patellar or tibial insertion in association with training and/or competition.
- Current symptom duration of at least 12 weeks.
- Sports participation at least once a week for at least one year.
- Palpation tenderness to the corresponding painful area on the patellar tendon.
Key exclusion criteria (14 listed)
- Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout or rheumatoid arthritis) or familial hypercholesterolaemia.
- Daily use of drugs with a putative effect on the patellar tendon in the preceding year (e.g. fluoroquinolones and statins)
- Knee surgery without a full completion of the rehabilitation program in the history of the index knee
- Previous patellar tendon rupture of the index knee
- Local injection therapy with corticosteroids, other drugs, blood, platelet rich plasma or stem cells in the preceding 12 months
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 |
|---|---|---|
| Collagen + vitamin CParticipants take the supplement (or placebo) every day for 24 weeks. On three days per week they perform tendon loading exercises. | Dietary supplement | Placebo + progressive tendon loading therapy, Supplement + progressive tendon loading therapy |
Primary outcome
VISA-P Score
Time frame: after 6 weeks follow-up
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
VISA-P Score
Time frame: after 12 weeks follow-up
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
VISA-P Score
Time frame: after 18 weeks follow-up
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
VISA-P Score
Time frame: after 24 weeks follow-up
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
VISA-P Score
Time frame: after 52 weeks follow-up
The primary outcome measure will be the change in the Dutch version of the VISA-P score. This simple, validated, reliable and injury-specific questionnaire scores the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to participate in tendon-loading sports [1]. A VISA-P score of 100 indicates no pain, maximum function and maximum ability to play sports. The score decreases with increasing severity of symptoms of PT. The VISA-P questionnaire will be self-administered at baseline, and after 6, 12, 18, 24 and 52 weeks follow-up
13 secondary outcomes
Pain during functional tests
Time frame: after 12 weeks follow-up
Pain during functional tests
Time frame: after 24 weeks follow-up
Imaging methods
Time frame: after 12 weeks follow-up
Imaging methods
Time frame: after 24 weeks follow-up
Stiffness measurement
Time frame: after 12 weeks follow-up
Stiffness measurement
Time frame: after 24 weeks follow-up
Blood levels of amino acids
Time frame: after 12 weeks follow-up
Blood levels of amino acids
Time frame: after 24 weeks follow-up
Blood levels of inflammatory markers
Time frame: after 12 weeks follow-up
Blood levels of inflammatory markers
Time frame: after 24 weeks follow-up
Dietary habits
Time frame: baseline
Dietary habits
Time frame: after 24 weeks
Compliance
Time frame: Weekly during the intervention, up to 24 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 38017500van Dam L, Terink R, Mensink M, de Vos RJ, Zwerver J. The JUMPFOOD study: additional effect of hydrolyzed collagen and vitamin C to exercise treatment for patellar tendinopathy (jumper's knee) in athletes-study protocol for a double-blind randomized controlled trial. Trials. 2023 Nov 28;24(1):768. doi: 10.1186/s13063-023-07783-2.
- Individual participant dataSharing planned: No. patient data, not able to share
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Anterior Knee Pain, Photobiomodulation (PBM)
Recruiting
Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk
Patellar Tendinitis, Jumper's Knee
Active, not recruiting
Chronic Patellar Tendinopathy (PT)is Prevalent in Participants of Several Sports.A Three-arm, Single-blind Randomized Controlled Trial Will be Conducted. We Want to Compare the Clinical Effectiveness of ESWT Alone, ESWT Combined With Hyaluronic Acid, and ESWT Combined With PRP in Athletes With PT
Chronic Patellar Tendinopathy
Enrolling by invitation
Effects of Resistance Training on Patellar Tendon Properties in People With Patellar Tendinoapthy
Patellar Tendinopathy
Active, not recruiting
Unlocking the Hidden Effects of Shockwave: Longitudinal Changes in Sensorimotor Function and Kinesiophobia in Adolescents With Patellar Tendinopathy
Patellar Tendinopathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen + vitamin C in people with Patellar Tendinopathy, run by Gelderse Vallei Hospital at 1 site in Netherlands.
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 8 inclusion and 14 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 26 Sep 2024. 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISA-P Score (time frame: after 6 weeks follow-up). The study lists 5 primary outcomes in all. 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 NCT05407194, which also lists 1 linked publication.
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 26 Sep 2024.