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Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

NCT ID: NCT03866200

Last Updated: 2022-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-29

Study Completion Date

2020-10-28

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.

Detailed Description

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Conditions

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Pseudoachondroplasia

Keywords

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resveratrol joint pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

resveratrol

Intervention Type DRUG

125 mg/day or 5 ml once per day for 90 days

Placebo

Intervention Type DRUG

5 ml once per day for 90 days

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.

Group Type PLACEBO_COMPARATOR

resveratrol

Intervention Type DRUG

125 mg/day or 5 ml once per day for 90 days

Placebo

Intervention Type DRUG

5 ml once per day for 90 days

Interventions

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resveratrol

125 mg/day or 5 ml once per day for 90 days

Intervention Type DRUG

Placebo

5 ml once per day for 90 days

Intervention Type DRUG

Other Intervention Names

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resverages super berry tonic

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Karen Posey

Assoc. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Posey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Health Science Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MS-17-0573

Identifier Type: -

Identifier Source: org_study_id