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Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites revised (3)v3
  2. Study sites: 1 to 3
    • Study description expanded, about 9 words
    • Collaborators: 5 to 7
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria). Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen). Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning. Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates.
Trial Details
NCT Number NCT06273644
Lead Sponsor Nordlandssykehuset HF
Collaborators: University of Oslo, Nord University, UiT The Arctic University of Norway, Norwegian University of Science and Technology, The University of Texas Medical Branch, Galveston, Karolinska University Hospital, University Hospital, Umeå
Conditions
(from sponsor)		 Porphyria, Acute Intermittent
Related terms Porphyria, Acute Intermittent
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov