Trial · NCT01772758
Cystic Fibrosis and Endothelial Function: At Rest and During Exercise
NCT01772758, Phase 2, Completed, Augusta University; results first posted 2018-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cystic Fibrosis and Endothelial Function: At Rest and During Exercise. Trials, record NCT01772758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01772758
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cystic Fibrosis and Endothelial Function: At Rest and During Exercise
- NCT number
- NCT01772758
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Cystic Fibrosis
- Interventions
- BH4 5mg, BH4 20mg, Antioxidant Cocktail
- First posted
- 2013-01-21
- Last updated
- 2019-06-20
- Results first posted
- 2018-01-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Flow-Mediated Dilation (FMD) | pre-treatment Baseline and 2-3 hours post-treatment | Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Flow-Mediated Dilation (FMD) | pre-treatment Baseline and 2-3 hours post-treatment | Participants included patients diagnosed with cystic fibrosis and healthy age-matched controls. | percentage of change in FMD | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Flow-Mediated Dilation (FMD) | Protocol 1: AOC | Pre treatment | 5.64 | Standard Deviation 2.80 | percentage of change in FMD |
| Percentage Flow-Mediated Dilation (FMD) | Protocol 2: BH4 (5mg) | Pre treatment | 5.32 | Standard Deviation 3.53 | percentage of change in FMD |
| Percentage Flow-Mediated Dilation (FMD) | Protocol 2: BH4 (20mg) | Pre treatment | 6.29 | Standard Deviation 3.21 | percentage of change in FMD |
| Percentage Flow-Mediated Dilation (FMD) | Healthy Controls | Pre treatment | 7.21 | Standard Deviation 3.17 | percentage of change in FMD |
| Percentage Flow-Mediated Dilation (FMD) | Protocol 1: AOC | Post treatment | 7.58 | Standard Deviation 4.16 | percentage of change in FMD |
| Percentage Flow-Mediated Dilation (FMD) | Protocol 2: BH4 (5mg) | Post treatment | 4.81 | Standard Deviation 2.83 | percentage of change in FMD |
| Percentage Flow-Mediated Dilation (FMD) | Protocol 2: BH4 (20mg) | Post treatment | 7.39 | Standard Deviation 3.41 | percentage of change in FMD |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Protocol 1: AOC | 18 | |
| Overall Study | STARTED | Protocol 2: BH4 (5mg) | 17 | |
| Overall Study | STARTED | Protocol 2: BH4 (20mg) | 12 | |
| Overall Study | STARTED | Healthy Controls | 17 | |
| Overall Study | COMPLETED | Protocol 1: AOC | 18 | |
| Overall Study | COMPLETED | Protocol 2: BH4 (5mg) | 17 | |
| Overall Study | COMPLETED | Protocol 2: BH4 (20mg) | 12 | |
| Overall Study | COMPLETED | Healthy Controls | 17 | |
| Overall Study | NOT COMPLETED | Protocol 1: AOC | 0 | |
| Overall Study | NOT COMPLETED | Protocol 2: BH4 (5mg) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antioxidant Cocktail: CF Patients | ||
| Total, all-cause mortality | Antioxidant Cocktail: Healthy Controls | ||
| Total, all-cause mortality | Tetrahydrobiopterin (BH4): 5mg | ||
| Total, all-cause mortality | Tetrahydrobiopterin (BH4): 20mg | ||
| Total, other adverse events | Antioxidant Cocktail: CF Patients | 0 | 18 |
| Total, other adverse events | Antioxidant Cocktail: Healthy Controls | 0 | 17 |
| Total, other adverse events | Tetrahydrobiopterin (BH4): 5mg | 0 | 17 |
| Total, other adverse events | Tetrahydrobiopterin (BH4): 20mg | 0 | 12 |
| Total, serious adverse events | Antioxidant Cocktail: CF Patients | 0 | 18 |
| Total, serious adverse events | Antioxidant Cocktail: Healthy Controls | 0 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT01772758
GET https://conductscience.org/api/trials/v1/NCT01772758/registered