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Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF

Study acronym: CF-AOX
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 2024 to Dec 2026
    • Study completion date: Jan 2025 to Jan 2027
    v13
  2. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Jan 2024 to Jan 2025
    v12
  3. Primary completion date: Dec 2021 to Dec 2023v11 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 13
    • Study completion date: Dec 2021 to Jan 2024
    • Site details revised
  4. Primary and study completion dates: Dec 2020 to Dec 2021v10
  5. Primary and study completion dates: Dec 2019 to Dec 2020v9
Show 7 earlier versionsHide 7 earlier versions
  1. Interventions: Acute Antioxidant Cocktail (Dietary Supplement), Chronic Antioxidant Cocktail (Dietary Supplement), Placebo (Other) to Acute Antioxidant (Dietary Supplement), Chronic Antioxidant (Dietary Supplement), Placebo (Other)
    • Secondary endpoints shortened, about 52 words
    • Site contact updated
    v8
  2. Primary and study completion dates: Dec 2018 to Dec 2019v7
  3. Primary completion date: Dec 2017 to Dec 2018v6
  4. Study completion date: Dec 2017 to Dec 2018v5
  5. Re-verified, no change to tracked fieldsv4
  6. Study description expanded, about 1 wordv3
  7. Secondary endpoints: 4 to 8
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. The investigators recently published the first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF. This study will look at how and if oxidative stress contributes to both artery dysfunction and exercise intolerance in CF.
Trial Details
NCT Number NCT02690064
Lead Sponsor Augusta University
Conditions
(from sponsor)		 Cystic Fibrosis
Related terms Cystic Fibrosis
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov