SLCTR/2023/016RecruitingPhase 2
A double-blind randomized controlled trial to investigate the effectiveness and safety of Retinyl Palmitate in patients with chronic Achilles tendinopathy.
Regenall (UK)0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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