Effect of Collagen/Vitamin C in Jumper's Knee; a RCT

NCT05407194 | Recruiting

• 1 other identifier: NL79100.081.21
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Patellar Tendinopathy

Keywords

collagen; progressive tendon loading therapy; gelatin; RCT

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  after 52 weeks follow-up

Secondary Outcomes (13)

• Pain during functional tests

  after 12 weeks follow-up

• Pain during functional tests

  after 24 weeks follow-up

• Imaging methods

  after 12 weeks follow-up

• Imaging methods

  after 24 weeks follow-up

• Stiffness measurement

  after 12 weeks follow-up

Study Arms (2)

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.

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.

Dietary Supplement: Collagen + vitamin C

Interventions

Collagen + vitamin C DIETARY_SUPPLEMENT

Participants take the supplement (or placebo) every day for 24 weeks. On three days per week they perform tendon loading exercises.

Placebo + progressive tendon loading therapy; Supplement + progressive tendon loading therapy

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Gelderse Vallei Hospital: lead

Study Sites (1)

Gelderse Vallei Hospital

Ede, Gelderland, 6716RP, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 38017500 DERIVED

MeSH Terms

Interventions

Collagen; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Supplement and placebo will be blinded for participants and researchers working on the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific researcher

Model Details: RCT

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: June 7, 2022
• Study Start: April 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)