A double-blind randomized placebo controlled trial to investigate the effectiveness and safety of Retinyl Palmitate in patients with chronic Achilles tendinopathy
- Conditions
- Achilles tendinopathy
- Registration Number
- SLCTR/2023/016
- Lead Sponsor
- Regenall (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
a. Both male and female >=18 years
b. Participating in competitive sport
c. Confirmed clinical and /or imaging-based (MRI or Grey-scale ultrasound) diagnosis of chronic mid-portion Achilles tendinopathy
d. Unable to regularly participate in their sport due to Achilles tendinopathy for the past minimum 3 months but no longer than 6 months
a.Previous Achilles tendon rupture on the affected side
b.Previous Achilles tendon surgery on the affected side
c.History of traumatic tears
d.Unable or unwilling to adhere to standardised rehabilitation programme
e.Previous history of arrythmias
f.History of myocardial infarction or unstable angina within the past 12 months
g.History of retinopathy
h.Participant is already taking Vitamin A supplementation or other retinoid derivatives
i.Participant is taking tetracyclines
j.Known hereditary thrombophilia (Factor V Leiden, Protein C/ S deficiency, anti-phospholipid or anti-cardiolipin antibodies)
k.Use of Vitamin K antagonist (such as Warfarin)
l.Hepatic impairment (AST or ALT > 3 x upper limit of normal)
m.Renal impairment (eGFR <10ml/ minute)
n.History of moderate or severe hypercalcaemia (total albumin-corrected calcium > 3.0mmol/l)
o.Active cancer (or recent cancer diagnosis within 6 months of screening)
p.History of allergy or intolerance to retinoids
q.Previous history of difficult to manage psychiatric disorders or history of suicidal ideation
r.Pregnant or breast-feeding (or not willing to use an approved contraceptive method during treatment and for at least 1-month post treatment)
s.Current enrolment in another interventional clinical trial
t.Unable to tolerate oral medications
u.Gastrointestinal problems that may affect oral drug absorption such as fat malabsorption
v.Pancreatic disease
w.Not able to consume fish oils/ gelatine-containing substances due to religious, cultural, health or other personal reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demonstrable changes from the baseline in tendon echo-pattern and fibre type as quantified by serial Ultrasound scanning [Baseline, 4 weeks, 8 weeks, 12 weeks, 18 weeks, and 26 weeks]<br>
- Secondary Outcome Measures
Name Time Method Pain interference and disability assessed by the VISA-A Questionnaire. <br><br>https://www.physiotutors.com/questionnaires/visa-a-achilles-questionnaire/ [Baseline, 4 weeks, 8 weeks, 12 weeks, 18 weeks, and 26 weeks]<br>Time to return to sport <br> [Calculation of days from date of injury to the date of starting the sport back]<br>Achilles tendon capacity measured by Calf raise to Fatigue test, compared against the baseline and the unaffected side at specified time points. [Baseline, 4 weeks, 8 weeks, 12 weeks, 18 weeks, and 26 weeks]<br>Achilles tendon flexibility measured by Knee-to-Wall test, compared against the baseline and the unaffected side at specified time points. [Baseline, 4 weeks, 8 weeks, 12 weeks, 18 weeks, and 26 weeks]<br> Steady state concentration of the retinyl palmitate level in the blood will be calculated using Vitamin A test [ 12 weeks and 26 weeks]<br>