Pseudoachondroplasia
Conditions
Keywords
resveratrol, joint pain
Brief summary
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.
Interventions
DRUGresveratrol
125 mg/day or 5 ml once per day for 90 days
DRUGPlacebo
5 ml once per day for 90 days
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by Numeric Pain Rating Scale | baseline, 30 days, 60 days, 90 days | total score 0-10 with higher scores indicating greater pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | baseline, 30 days, 60 days, 90 days | total score 0-100 with higher scores indicating better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
resveratrol: 125 mg/day or 5 ml once per day for 90 days | 5 |
| 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.
Placebo: 5 ml once per day for 90 days | 1 |
| Total | 6 |
Baseline characteristics
| Characteristic | Resveratrol, Then Placebo | Total | Placebo, Then Resveratrol |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 16.36 | 51.67 years STANDARD_DEVIATION 14.69 | 49 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 1 Participants |
| Region of Enrollment United States | 5 participants | 6 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Pain as Assessed by Numeric Pain Rating Scale
total score 0-10 with higher scores indicating greater pain
Time frame: baseline, 30 days, 60 days, 90 days
Population: Data were not collected for one participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Resveratrol | Pain as Assessed by Numeric Pain Rating Scale | Baseline | 3.60 score on a scale | Standard Deviation 1.36 |
| Resveratrol | Pain as Assessed by Numeric Pain Rating Scale | 30 days | 2.72 score on a scale | Standard Deviation 1.24 |
| Resveratrol | Pain as Assessed by Numeric Pain Rating Scale | 60 days | 2.44 score on a scale | Standard Deviation 1.36 |
| Resveratrol | Pain as Assessed by Numeric Pain Rating Scale | 90 days | 2.55 score on a scale | Standard Deviation 0.92 |
| Placebo | Pain as Assessed by Numeric Pain Rating Scale | 90 days | 1.92 score on a scale | Standard Deviation 0.7 |
| Placebo | Pain as Assessed by Numeric Pain Rating Scale | Baseline | 3.60 score on a scale | Standard Deviation 1.36 |
| Placebo | Pain as Assessed by Numeric Pain Rating Scale | 60 days | 2.10 score on a scale | Standard Deviation 1.09 |
| Placebo | Pain as Assessed by Numeric Pain Rating Scale | 30 days | 2.36 score on a scale | Standard Deviation 1 |
Secondary
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
Time frame: baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Resveratrol | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | Baseline | 68.60 score on a scale | Standard Deviation 13.06 |
| Resveratrol | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | 30 days | 76.30 score on a scale | Standard Deviation 11.23 |
| Resveratrol | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | 60 days | 70.17 score on a scale | Standard Deviation 16.56 |
| Resveratrol | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | 90 days | 76.71 score on a scale | Standard Deviation 14.27 |
| Placebo | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | 90 days | 77.54 score on a scale | Standard Deviation 14.34 |
| Placebo | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | Baseline | 68.60 score on a scale | Standard Deviation 13.06 |
| Placebo | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | 60 days | 80.33 score on a scale | Standard Deviation 13.46 |
| Placebo | Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36) | 30 days | 75.84 score on a scale | Standard Deviation 13.78 |