Trial · NCT03253913
Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial
NCT03253913, Phase 2, Completed, University of Cincinnati; results first posted 2023-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial. Trials, record NCT03253913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03253913
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial
- NCT number
- NCT03253913
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of Cincinnati
- Conditions
- Lymphangioleiomyomatosis
- Interventions
- Sirolimus, Resveratrol
- First posted
- 2017-08-18
- Last updated
- 2023-02-01
- Results first posted
- 2023-02-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels After Treatment With a Combination of Resveratrol and Sirolimus as Compared to Baseline Serum VEGF-D Levels on Sirolimus Alone | Baseline, Week 8, Week 16, Week 24 | Change in serum VEGF-D level in pg/ml after treatment with a combination of resveratrol and sirolimus as compared to the historical VEGF-D level in patients on a stable dose of sirolimus alone. Baseline VEGF-D values represent serum VEGF-D levels on stable dose of sirolimus alone prior to starting study drug. |
| Secondary | Number of Treatment-Emergent Adverse Events | Baseline, Week 8, Week 16, Week 24 | Safety and adverse effect profile of combined resveratrol and sirolimus in adult patients with LAM |
| Secondary | Change in Forced Expiratory Volume in One-second (FEV1) After 24 Weeks of Combined Treatment With Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24 | Difference in the absolute Forced expiratory volume in one-second (FEV1) after 24 weeks of treatment. FEV1 values reported are in liters. There are no definite minimum and maximum values of FEV1 as it is a physiological measure of lung function and varies from individual to individual. Higher FEV1 scores indicate better lung function. |
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Quality of Life Assessment Scores After Treatment With Combined Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24. | Quality of life scores will be calculated by using SGRQ to determine if the combination of resveratrol and sirolimus can improve the quality of life in patients with LAM. This is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating worse quality of life. |
| Secondary | Scores on "A Tool to Assess Quality of Life in LAM (ATAQ-LAM) Quality of Life Assessment" Scale After Treatment With 24 Weeks of Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24 | Quality of life scores will be calculated by using ATAQ-LAM to determine if the combination of resveratrol and sirolimus can improve the quality of life in patients with LAM. A Tool to Assess Quality of Life in LAM (ATAQ-LAM) is a disease-specific instrument designed to assess HRQOL in patients with LAM, and consists of 32 items divided into 4 domains: exertional dyspnea, cough, fatigue, and emotional well-being. The total scores on this scale can range between 32 - 192, with higher scores indicating worse quality of life. |
| Secondary | San Diego Shortness of Breath Score (SD-SOB) Quality of Life Assessment Scores After Treatment With 24 Weeks of Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24 | The San Diego shortness of breath questionnaire measures the quality-of-life impairment secondary to dyspnea resulting from pulmonary disorders. It is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living, with higher scores indicating worse quality of life. |
| Secondary | EuroQOL Visual Analogue Scale (EQ-5D) Scores After Treatment With 24 Weeks of Sirolimus and Resveratrol. | Baseline, Week 8, Week 16, Week 24 | The EuroQOL visual-analogue scale (EQVAS) measures self-reported ratings of health status. Scores range from 0 to100, with lower scores indicating worse functioning. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels After Treatment With a Combination of Resveratrol and Sirolimus as Compared to Baseline Serum VEGF-D Levels on Sirolimus Alone | Baseline, Week 8, Week 16, Week 24 | Longitudinal slope of serum VEGF-D levels | pg/ml | MEDIAN |
| SECONDARY | Number of Treatment-Emergent Adverse Events | Baseline, Week 8, Week 16, Week 24 | Adverse effects | NUMBER | |
| SECONDARY | Change in Forced Expiratory Volume in One-second (FEV1) After 24 Weeks of Combined Treatment With Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24 | Absolute FEV1 in liters | MEDIAN | |
| SECONDARY | St. George's Respiratory Questionnaire (SGRQ) Quality of Life Assessment Scores After Treatment With Combined Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24. | score on a scale | MEDIAN | |
| SECONDARY | Scores on A Tool to Assess Quality of Life in LAM (ATAQ-LAM) Quality of Life Assessment Scale After Treatment With 24 Weeks of Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24 | score on a scale | MEDIAN | |
| SECONDARY | San Diego Shortness of Breath Score (SD-SOB) Quality of Life Assessment Scores After Treatment With 24 Weeks of Resveratrol and Sirolimus | Baseline, Week 8, Week 16, Week 24 | score on a scale | MEDIAN | |
| SECONDARY | EuroQOL Visual Analogue Scale (EQ-5D) Scores After Treatment With 24 Weeks of Sirolimus and Resveratrol. | Baseline, Week 8, Week 16, Week 24 | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels After Treatment With a Combination of Resveratrol and Sirolimus as Compared to Baseline Serum VEGF-D Levels on Sirolimus Alone | Treatment Arm | Baseline VEGF-D level in patients on a stable dose of sirolimus alone | 617 | Inter-Quartile Range 489 to 677 | pg/ml |
| Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels After Treatment With a Combination of Resveratrol and Sirolimus as Compared to Baseline Serum VEGF-D Levels on Sirolimus Alone | Treatment Arm | Week 8 | 543 | Inter-Quartile Range 455 to 704 | pg/ml |
| Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels After Treatment With a Combination of Resveratrol and Sirolimus as Compared to Baseline Serum VEGF-D Levels on Sirolimus Alone | Treatment Arm | Week 16 | 581 | Inter-Quartile Range 485 to 724 | pg/ml |
| Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels After Treatment With a Combination of Resveratrol and Sirolimus as Compared to Baseline Serum VEGF-D Levels on Sirolimus Alone | Treatment Arm | Week 24 | 575 | Inter-Quartile Range 448 to 673 | pg/ml |
| Number of Treatment-Emergent Adverse Events | Treatment Arm | 250 mg daily | 42 | Adverse effects | |
| Number of Treatment-Emergent Adverse Events | Treatment Arm | 500mg daily | 25 | Adverse effects | |
| Number of Treatment-Emergent Adverse Events | Treatment Arm | 1000mg daily | 25 | Adverse effects | |
| Change in Forced Expiratory Volume in One-second (FEV1) After 24 Weeks of Combined Treatment With Resveratrol and Sirolimus | Treatment Arm | Baseline | 1.74 | Inter-Quartile Range 1.46 to 2.3 | Absolute FEV1 in liters |
| Change in Forced Expiratory Volume in One-second (FEV1) After 24 Weeks of Combined Treatment With Resveratrol and Sirolimus | Treatment Arm | Week 8 | 1.98 | Inter-Quartile Range 1.4 to 2.36 | Absolute FEV1 in liters |
| Change in Forced Expiratory Volume in One-second (FEV1) After 24 Weeks of Combined Treatment With Resveratrol and Sirolimus | Treatment Arm | Week 16 | 2.01 | Inter-Quartile Range 1.18 to 2.57 | Absolute FEV1 in liters |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First 8 Weeks (250mg Daily Resveratrol) | STARTED | Treatment Arm | 25 | |
| First 8 Weeks (250mg Daily Resveratrol) | COMPLETED | Treatment Arm | 25 | |
| First 8 Weeks (250mg Daily Resveratrol) | NOT COMPLETED | Treatment Arm | 0 | |
| Weeks 8 - 16 (Resveratrol 500mg Daily) | STARTED | Treatment Arm | 25 | |
| Weeks 8 - 16 (Resveratrol 500mg Daily) | COMPLETED | Treatment Arm | 25 | |
| Weeks 8 - 16 (Resveratrol 500mg Daily) | NOT COMPLETED | Treatment Arm | 0 | |
| Weeks 16-24 (Resveratrol 1,000mg Daily) | STARTED | Treatment Arm | 25 | |
| Weeks 16-24 (Resveratrol 1,000mg Daily) | COMPLETED | Treatment Arm | 25 | |
| Weeks 16-24 (Resveratrol 1,000mg Daily) | NOT COMPLETED | Treatment Arm | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | 250mg Resveratrol Daily (First 8 Weeks) | 3 | 25 | 4 |
| other | nausea | Gastrointestinal disorders | 500mg Daily Resveratrol (Weeks 8 - 16) | 2 | 25 | 2 |
| other | nausea | Gastrointestinal disorders | 1,000mg Daily Resveratrol | 2 | 25 | 3 |
| other | diarrhea | Gastrointestinal disorders | 250mg Resveratrol Daily (First 8 Weeks) | 4 | 25 | 4 |
| other | diarrhea | Gastrointestinal disorders | 500mg Daily Resveratrol (Weeks 8 - 16) | 1 | 25 | 1 |
| other | diarrhea | Gastrointestinal disorders | 1,000mg Daily Resveratrol | 0 | 25 | 0 |
| other | gastrointestinal discomfort | Gastrointestinal disorders | 250mg Resveratrol Daily (First 8 Weeks) | 3 | 25 | 3 |
| other | gastrointestinal discomfort | Gastrointestinal disorders | 500mg Daily Resveratrol (Weeks 8 - 16) | 1 | 25 | 2 |
| other | gastrointestinal discomfort | Gastrointestinal disorders | 1,000mg Daily Resveratrol | 3 | 25 | 4 |
| other | Infection | Infections and infestations | 250mg Resveratrol Daily (First 8 Weeks) | 6 | 25 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 250mg Resveratrol Daily (First 8 Weeks) | 0 | 25 |
| Total, all-cause mortality | 500mg Daily Resveratrol (Weeks 8 - 16) | 0 | 25 |
| Total, all-cause mortality | 1,000mg Daily Resveratrol | 0 | 25 |
| Total, other adverse events | 250mg Resveratrol Daily (First 8 Weeks) | 14 | 25 |
| Total, other adverse events | 500mg Daily Resveratrol (Weeks 8 - 16) | 5 | 25 |
| Total, other adverse events | 1,000mg Daily Resveratrol | 6 | 25 |
| Total, serious adverse events | 250mg Resveratrol Daily (First 8 Weeks) | 0 | 25 |
| Total, serious adverse events | 500mg Daily Resveratrol (Weeks 8 - 16) | 0 | 25 |
| Total, serious adverse events | 1,000mg Daily Resveratrol | 0 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36642366 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34HL138235 | Resveratrol and Sirolimus in LAM Trial (RESULT) | GUPTA, NISHANT | UNIVERSITY OF CINCINNATI | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03253913
GET https://conductscience.org/api/trials/v1/NCT03253913/results?page=2