Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Resveratrol, Then Placebo 		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
    125 mg/day or 5 ml once per day for 90 days
    Other names:
    • resverages super berry tonic
  • Drug: Placebo
    5 ml once per day for 90 days
Placebo Comparator
Placebo, Then Resveratrol 		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
    125 mg/day or 5 ml once per day for 90 days
    Other names:
    • resverages super berry tonic
  • Drug: Placebo
    5 ml once per day for 90 days

More Details

Status
Terminated
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.