An interventional study of Collagen + vitamin C in Patellar Tendinopathy, sponsored by Gelderse Vallei Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 16 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Gelderse Vallei Hospital · Not applicable, Interventional, and Treatment
Among 10 studies in Tendinopathy with a site in Netherlands — 3 open to participants now, 3 under way, 1 of them phase 3. Tendinopathy · Netherlands.
Among the 10 studies in Tendinopathy with a site in Netherlands, this one is the 9th largest by planned enrollment, is the only one that started in 2023, is one of 5 with no phase, and was the 8th registered.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
Browse Tendinopathy studies →3 of the 10 studies in Tendinopathy with a site in Netherlands are open now. Recruiting first, the newest first:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Netherlands
Ages 18+
Erasmus Medical Center · Sites in Netherlands
Ages 18–65
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 47 Tendinopathy studies recruiting now, 16 (34%) set no upper age limit and 24 (51%) stop at 75 or younger; 1 takes children under 18; 7 take healthy volunteers.
This study: 16 Years to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 2 · Phase 4 2
First in 2008; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 76 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.
Median enrollment 81 across the 10 interventional studies. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 10 have an industry lead sponsor. The 7 most frequent:
Gelderse Vallei Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Gelderse Vallei Hospital has 1 study filed under Tendinopathy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Tendinopathy with a site in Netherlands, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Collagen + vitamin C
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.
Dietary Supplement: Collagen + vitamin C
Drug pages: Collagen · Ascorbic Acid
Participants take the supplement (or placebo) every day for 24 weeks. On three days per week they perform tendon loading exercises.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after 52 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: baseline
Dietary habits
Dietary habits (nutritional intake) will be measured at the start and end of the intervention period using a diary.
Time frame: 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
Time frame: Weekly during the intervention, up to 24 weeks follow-up
Plan to share: No — patient data, not able to share
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for May 2025, 25 months after the start.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 25 months is above that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Collagen · Ascorbic Acid
Gelderse Vallei Hospital