Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet

StatusEnrolling by Invitation
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Jan 2027 → Jun 2028
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Record History

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  1. Primary completion pushed from Jan 2027 to Jun 2028
    • Study completion pushed from Dec 2027 to Dec 2028
    • Eligibility criteria expanded, about 13 words
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2024 to Oct 4, 2024
    v6
  4. Start date: Sep 2024 to Oct 2024v5
  5. Start date: Aug 2024 to Sep 2024v4
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  1. Start date: Jul 2024 to Aug 2024v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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.
Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol.
Trial Details
NCT Number NCT06369571
Lead Sponsor Johns Hopkins University
Collaborators: American Heart Association
Conditions
(from sponsor)		 Epilepsy, Dyslipidemia
Related terms Dyslipidemias, Epilepsy
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov