Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

Study Overview
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Brief Summary
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The purpose of this study is to determine if self-administered oral resveratrol can dampen joint pain for individuals with pseudoachondroplasia compared to placebo. Another goal of this study is to evaluate side effects in this population.

Official Title
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Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

Conditions
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Pseudoachondroplasia

Intervention / Treatment
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* Drug: resveratrol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of pseudoachondroplasia is based on clinical assessment either in person or by photographic review by skeletal dysplasia specialist (JTH), Healthy beyond pseudoachondroplasia associated complications, Exclusion Criteria: Current use of resveratrol Current use of blood thinners, lovastatin, ketoconazole, itraconazole, fexofenadine and triazolam. Other non-pseudoachondroplasia related health conditions, e.g. cancers. Pregnancy or breastfeeding. Women must use adequate contraception during the study. Participation in another clinical study and/or using investigational agents. Use of Non-steroid anti-inflammatory (NSAIDs) or aspirin. Current use of Alfentanil, Cyclosporine, Dihydroergotamine, Dofetilide, Ergotamine, Fentanyl, Flibanserin, Oxycodone, Pimavanserin, Pimozide, Quinidine, Saquinavir, Sirolimus, Tacrolimus, Temsirolimus, Theophylline, Tizanidine, Thioridazine, Fosphenytoin, Phenytoin or Warfarin. Baseline level of pain of 2 or higher on 10 point scale. Platelet count below 50,000 per ul on baseline complete blood count (CBC).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol, Then Placebo<br>Participants first received Resveratrol 125 mg/day or 5 ml daily for 90 days. After a washout period of 30 days, they then received Placebo 5ml daily for 90 days. | Drug: resveratrol<br>* 125 mg/day or 5 ml once per day for 90 days<br>* Other names: resverages super berry tonic;Drug: Placebo<br>* 5 ml once per day for 90 days<br>|
| Placebo Comparator: Placebo, Then Resveratrol<br>Participants first received Placebo 5ml daily for 90 days. After a washout period of 30 days, they then received Resveratrol 125 mg/day or 5 ml daily for 90 days. | Drug: resveratrol<br>* 125 mg/day or 5 ml once per day for 90 days<br>* Other names: resverages super berry tonic;Drug: Placebo<br>* 5 ml once per day for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as Assessed by Numeric Pain Rating Scale | total score 0-10 with higher scores indicating greater pain | baseline, 30 days, 60 days, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | total score 0-100 with higher scores indicating better outcome | baseline, 30 days, 60 days, 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resveratrol, joint pain