A Phase 2 interventional study of resveratrol and Placebo in Pseudoachondroplasia, sponsored by The University of Texas Health Science Center, Houston. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment
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.
47 studies on the registry are indexed under Achondroplasia; 14 are open to participants now.
This study's enrollment of 6 is below the median of 73 across 28 interventional studies indexed under Achondroplasia.
Browse Achondroplasia studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Placebo
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 · Drug: Placebo
125 mg/day or 5 ml once per day for 90 days
Also known as: resverages super berry tonic
5 ml once per day for 90 days
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
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
| Milestone | Resveratrol, Then Placebo | Placebo Comparator: Placebo, Then Resveratrol |
|---|---|---|
| Started | 5 | 1 |
| Completed | 5 | 1 |
| Not completed | 0 | 0 |
| Milestone | Resveratrol, Then Placebo | Placebo Comparator: Placebo, Then Resveratrol |
|---|---|---|
| Started | 5 | 1 |
| Completed | 5 | 1 |
| Not completed | 0 | 0 |
| Milestone | Resveratrol, Then Placebo | Placebo Comparator: Placebo, Then Resveratrol |
|---|---|---|
| Started | 5 | 1 |
| Completed | 5 | 1 |
| Not completed | 0 | 0 |
total score 0-10 with higher scores indicating greater pain
| score on a scale | Resveratrol | Placebo |
|---|---|---|
| Baseline | 3.60 ± 1.36 | 3.60 ± 1.36 |
| 30 days | 2.72 ± 1.24 | 2.36 ± 1.00 |
| 60 days | 2.44 ± 1.36 | 2.10 ± 1.09 |
| 90 days | 2.55 ± 0.92 | 1.92 ± 0.70 |
total score 0-100 with higher scores indicating better outcome
| score on a scale | Resveratrol | Placebo |
|---|---|---|
| Baseline | 68.60 ± 13.06 | 68.60 ± 13.06 |
| 30 days | 76.30 ± 11.23 | 75.84 ± 13.78 |
| 60 days | 70.17 ± 16.56 | 80.33 ± 13.46 |
| 90 days | 76.71 ± 14.27 | 77.54 ± 14.34 |
Collected over 90 days for each intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resveratrol | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Placebo | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Resveratrol, Then Placebo | Placebo, Then Resveratrol | Total |
|---|---|---|---|
| Mean | 52.2 ± 16.36 | 49 ± 0 | 51.67 ± 14.69 |
| Sex: Female, Male(Participants) | Resveratrol, Then Placebo | Placebo, Then Resveratrol | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Resveratrol, Then Placebo | Placebo, Then Resveratrol | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 1 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Resveratrol, Then Placebo | Placebo, Then Resveratrol | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 1 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Resveratrol, Then Placebo | Placebo, Then Resveratrol | Total |
|---|---|---|---|
| United States | 5 | 1 | 6 |
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The University of Texas Health Science Center, Houston