Actively Recruiting

Phase Not Applicable
Age: 16Years - 40Years
All Genders
Healthy Volunteers
NCT05407194

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

Led by Gelderse Vallei Hospital · Updated on 2024-09-26

76

Participants Needed

1

Research Sites

160 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 16Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 16 to 40 years old
  • History of focal knee pain in patellar tendon or its patellar or tibial insertion related to training or competition
  • Symptoms lasting at least 12 weeks
  • Participating in sports at least once a week for at least one year
  • Tenderness when pressing on the painful area of the patellar tendon
  • Focal patellar tendon pain during tendon loading tests (single leg decline squat and/or single leg jump squat)
  • Victorian Institute of Sports Assessment (VISA-P) score less than 80 out of 100
  • Willingness to take non-vegetarian nutritional supplements
Not Eligible

You will not qualify if you...

  • Known inflammatory joint diseases such as spondylarthropathy, gout, or rheumatoid arthritis, or familial hypercholesterolaemia
  • Daily use of drugs affecting the patellar tendon in the past year (e.g., fluoroquinolones, statins)
  • History of knee surgery without full rehabilitation on the study knee
  • Previous patellar tendon rupture of the study knee
  • Local injection therapy (corticosteroids, other drugs, blood, platelet rich plasma, or stem cells) in the past 12 months
  • Acute knee injuries including acute patellar tendon injuries
  • Inability to perform the tendon loading exercise program
  • Participation in other treatment programs at the same time
  • Signs or symptoms of other knee problems found on physical exam or additional tests (e.g., patellofemoral pain syndrome, joint effusion, joint line tenderness, chondral lesions, prepatellar bursitis)
  • Current use of collagen supplements
  • Blood donation within two months before each test day
  • Pregnancy or planning to become pregnant within the next year
  • Abuse of hard drugs
  • Alcohol consumption above 21 units/week for men or above 14 units/week for women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gelderse Vallei Hospital

Ede, Gelderland, Netherlands, 6716RP

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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