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Resveratrol Trial for Relief of Pain in Pseudoachondroplasia

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ClinicalTrials.gov Identifier: NCT03866200
Recruitment Status : Terminated (Inability to recruit target number)
First Posted : March 7, 2019
Results First Posted : December 9, 2022
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
Karen Posey, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pseudoachondroplasia
Interventions Drug: resveratrol
Drug: Placebo
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Resveratrol, Then Placebo Placebo Comparator: Placebo, Then Resveratrol
Hide Arm/Group Description

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

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
Period Title: First Intervention (90 Days)
Started 5 1
Completed 5 1
Not Completed 0 0
Period Title: Washout (30 Days)
Started 5 1
Completed 5 1
Not Completed 0 0
Period Title: Second Intervention (90 Days)
Started 5 1
Completed 5 1
Not Completed 0 0
Arm/Group Title Resveratrol, Then Placebo Placebo, Then Resveratrol Total
Hide Arm/Group Description

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

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

 Total of all reporting groups
Overall Number of Baseline Participants 5 1 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 1 participants 6 participants
52.2  (16.36) 49  (0) 51.67  (14.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 1 participants 6 participants
Female
2
  40.0%
0
   0.0%
2
  33.3%
Male
3
  60.0%
1
 100.0%
4
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 1 participants 6 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
1
 100.0%
6
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 1 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
1
 100.0%
6
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 1 participants 6 participants
5 1 6
1.Primary Outcome
Title Pain as Assessed by Numeric Pain Rating Scale
Hide Description total score 0-10 with higher scores indicating greater pain
Time Frame baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected for one participant
Arm/Group Title Resveratrol Placebo
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Participants who received Resveratrol 125 mg/day or 5 ml daily either the first or last 90 days of the study
Participants who received Placebo 5ml daily for either the first or last 90 days of the study.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
2.Secondary Outcome
Title Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
Hide Description total score 0-100 with higher scores indicating better outcome
Time Frame baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resveratrol Placebo
Hide Arm/Group Description:
Participants who received Resveratrol 125 mg/day or 5 ml daily either the first or last 90 days of the study
Participants who received Placebo 5ml daily for either the first or last 90 days of the study.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
Time Frame 90 days for each intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Resveratrol Placebo
Hide Arm/Group Description Participants who received Resveratrol 125 mg/day or 5 ml daily either the first or last 90 days of the study Participants who received Placebo 5ml daily for either the first or last 90 days of the study
All-Cause Mortality
Resveratrol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Resveratrol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Resveratrol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karen Posey, PhD
Organization: The University of Texas Health Science Center at Houston
Phone: 713-500-5786
EMail: karen.posey@uth.tmc.edu
Layout table for additonal information
Responsible Party: Karen Posey, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03866200    
Other Study ID Numbers: HSC-MS-17-0573
First Submitted: March 5, 2019
First Posted: March 7, 2019
Results First Submitted: November 18, 2022
Results First Posted: December 9, 2022
Last Update Posted: December 9, 2022