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Inability to recruit target number
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol, Then Placebo | Experimental | 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. |
|
| Placebo, Then Resveratrol | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resveratrol | Drug | 125 mg/day or 5 ml once per day for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain as Assessed by Numeric Pain Rating Scale | total score 0-10 with higher scores indicating greater pain | baseline, 30 days, 60 days, 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 30 days, 60 days, 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Posey, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Placebo: 5 ml once per day for 90 days |
| FG001 | 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. resveratrol: 125 mg/day or 5 ml once per day for 90 days Placebo: 5 ml once per day for 90 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (90 Days) |
| |||||||||||||
| Washout (30 Days) |
| |||||||||||||
| Second Intervention (90 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo, Then Resveratrol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain as Assessed by Numeric Pain Rating Scale | total score 0-10 with higher scores indicating greater pain | Data were not collected for one participant | Posted | Mean | Standard Deviation | score on a scale | baseline, 30 days, 60 days, 90 days |
|
90 days for each intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resveratrol | Participants who received Resveratrol 125 mg/day or 5 ml daily either the first or last 90 days of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Posey, PhD | The University of Texas Health Science Center at Houston | 713-500-5786 | karen.posey@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2020 | May 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C535819 | Pseudoachondroplasia |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | 5 ml once per day for 90 days |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | baseline, 30 days, 60 days, 90 days |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | Participants who received Placebo 5ml daily for either the first or last 90 days of the study | 0 | 6 | 0 | 6 | 0 | 6 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| 60 days |
|
| 90 days |
|