Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

November 18, 2022 updated by: Karen Posey, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain as Assessed by Numeric Pain Rating Scale
Time Frame: baseline, 30 days, 60 days, 90 days
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)
Time Frame: baseline, 30 days, 60 days, 90 days
total score 0-100 with higher scores indicating better outcome
baseline, 30 days, 60 days, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Karen Posey, PhD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2019

Primary Completion (Actual)

October 28, 2020

Study Completion (Actual)

October 28, 2020

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-17-0573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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