Porphyria, Acute IntermittentNCT06273644
Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment
A study testing Carbohydrates in people with Porphyria, Acute Intermittent, run by Nordlandssykehuset HF at 3 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Porphyria, Acute Intermittent
- What is being tested?
- Carbohydrates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Jan 2024to 31 Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AIP
Who cannot join
- Not having diagnosis of AIP
- Undergoing treatment as part of other clinical research on AIP
- Pregnancy
- Diabetes
- Below 18 years of age
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Sweden2 sites, 2 recruiting
- Recruiting
Studieenheten, Akademiskt Specialistcentrum, Stockholm läns sjukvårdsområde, Region Stockholm
Stockholm
Eliane Sardh, MD PhD, (0)70 003 98 78 ext. +46, eliane.sardh@regionstockholm.se
Lina Lundén-Bengtsberg, Master, (0)8-123 498 48 ext. +46, lina.lunden-bengtsberg@regionstockholm.se
- Recruiting
Norrland University Hospital
Umeå
Per Dahlqvist, MD PhD, 90-785 3390 ext. +46, per.dahlqvist@umu.se
Inger Arnesjø, Bachelor, 907854391 ext. +46, inger.arnesjo@umu.se
Norway1 site, 1 recruiting
- Recruiting
Nordland Hospital Trust
Bodø, Nordland, 8092
Elin Storjord, MD PhD, +4797072484, elin.storjord@nordlandssykehuset.no
Hilde Thunhaug, IC nurse, +47 95057864, hilde.thunhaug@nordlandssykehuset.no
About this study
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).
Read more
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.
Read the detailed description
Acute intermittent porphyria (AIP) is an inherited disease that leads to the accumulation of porphobilinogen (PBG), resulting in severe abdominal pain, paralysis, fatigue, low-grade inflammation, and an increased risk of kidney failure and liver cancer. Studies at the cellular level and in mice have shown that elevated levels of glucose and insulin can affect heme synthesis, potentially reducing PBG levels. The investigators have previously demonstrated that individuals with AIP consume less carbohydrate (E% 40) than recommended. The investigators aim to conduct a crossover study involving 50 participants with AIP, where 50% will be subjected to a 4-week intervention with 60-65 E% carbohydrates, while the other half will consume 40-45 E% carbohydrates for 4 weeks. After a 4-week intervention-free period, the two groups will switch to the respective carbohydrate percentages. Symptoms, PBG levels, continuous tissue glucose, plasma/serum insulin, glucose, cytokines, amino acid levels, microbiota in the gut, body composition, and physical activity measured using accelerometers will be assessed before and after each intervention and compared. Mitochondrial activity will be assessed at the cellular level as oxidative activity. Mutations in mitochondrial DNA and RNA will also be examined since defects in oxidative energy metabolism are known to be associated with inflammation and cancer. The work will be carried out at Nordland Hospital and at the University of Oslo. The study will be coordinated and conducted by the Postdoc and partners at Nordland Hospital, Karolinska University Hospital Stockholm and Norrland University Hospital, Umeå, the University of Oslo, the Arctic University of Tromsø, and Nord University. Clinical nutritionists will create dietary plans, and bioengineers will perform analyses. Stay abroad for postdoc, and research cooperation, with porphyria researchers at UTMB, Texas and MGH, Boston, US.
- Conditions
- Porphyria, Acute Intermittent
- Being tested
- Carbohydrates
- Medical subject headings
- Porphyria, Acute Intermittent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydratesOther
Half of the patients will initially follow Diet Plan A with 60-65 E% carbohydrates for 4 weeks, followed by a 4-week washout period, and then Diet Plan B with 40-45 E% carbohydrates for 4 weeks. The other half will start with Diet Plan B for 4 weeks, followed by a 4-week washout period, and then Diet Plan A for 4 weeks . Diet Plans A and B contain recommended and adequate nutrients according to the Nordic Nutrition Recommendations 2023 (NNR2023) for maintaining a stable weight.
| Study group | Role | What they receive |
|---|---|---|
| 60-65 E% Carbohydrates | Experimental | Diet plan A with 60-65 E% Carbohydrates in 4 weeks Receives: Other: Carbohydrates |
| 40-45% Carbohydrates | Active comparator | Diet plan B with 40-45 E% Carbohydrates in 4 weeks Receives: Other: Carbohydrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urine Porphobilinogen/creatinine
AIP biochemical disease activity. First morning Urine Porphobilinogen/creatinine.
Change from baseline before diet A to immediately after diet A, and change from baseline before diet B to immediately after diet B
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements
AIP biochemical disease activity, repeated measurements Percentage change in the median of repeated measurements of Urine Porphobilinogen/creatinine concentrations between Diet A and Diet B The repeated measurements in urine analyzed in urine samples from Day 1 ,4, 8, 11, 15, 18, 22, 25 and 29 of Diet A and of Diet B, and calculated median of Urine Porphobilinogen/creatinine concentration for diet A and median for diet B
Measured: Day 1 ,4, 8, 11, 15, 18, 22, 25 and 29 of Diet Intervention A and of Diet Intervention B
Secondary outcomes (18)
Number of Hospitalizations,sick leaves, and doctor visits due to AIP
Using questionnaire counting Number of hospitalizations, sick leaves, and doctor visits due to AIP
- In the 4 weeks before Diet A, measured at baseline immediately before Diet A
- In the 4 weeks of Diet A, measured immediately after Diet A.
- In the 4 weeks before Diet B, measured at baseline immediately before Diet B
- in the 4 weeks of Diet B, measured immediately after Diet B
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Health status
A standardized questionnaire assessing health (RAND-36) with a 4-week time frame from 0 (worst functioning) to 100 (best functioning), where 2 to 5 points represent a clinically meaningful difference based on data from other chronic diseases.
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Plasma Glucose level
Plasma glucose concentration
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Interstitial fluid glucose level
Glucose measured in the interstitial fluid (ISF) Measuring is performed continuously by ISF glucose sensor FreeStyle Libre 3 in the 4 weeks of Diet A and in the 4 weeks of Diet B. Outcome is percentage change in the mean of repeated measurements between Diet A and Diet B.
Each tissue glucose sensor lasts 14 days, and hence the outcome measure will be assessed each 14 days, and read in the LibreView program. The sensor is placed on the back of the participants upper arm
Measured: Day 15 and 29 of diet A and day 15 and 29 of diet B
Number of hypoglycemic events
Tissue glucose measured continuously by tissue glucose sensor FreeStyle Libre 3 (Abbott) in the 4 weeks during diet A and in the 4 weeks of diet B.
Counting number of hypoglycemic events during the 4 weeks of diet A and comparing to counted number of hypoglycemic events during the 4 weeks of diet B.
Each tissue glucose sensor lasts 14 days, and hence the outcome measure will be assessed each 14 days, and read in the LibreView program. Assessing is performed day 15 and day 29 of diet A and day 15 and 29 of diet B.
Measured: Day 15 and 29 of diet A and day 15 and 29 of diet B
Amino acid profile
Levels of amino acids measured
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Plasma insulin, glucose, c-peptide
Concentration levels measured in plasma
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
HOMA score
HOMA score (Homeostatic Model Assessment) including estimated beta cell function, HOMA%B (%B), insulin sensitivity, HOMA%S (%S), and insulin resistance HOMA-IR (IR), calculated from insulin, glucose and C-peptide in plasma, using an Excel spreadsheet from the University of Oxford.
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
HbA1c
Concentration levels measured in blood
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Cytokines in plasma
Cytokines, chemokines and growth factors measured using Multiplex assay from BioRad Lab, Bio-Plex 27-plex kit: Interleukin (IL)-1β, IL-1RA (IL-1 receptor antagonist), IL-2, IL-4, IL-5, IL-6, IL-7, chemokine (C-X-C) motif 8 (CXCL8), IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, chemokine (C-C motif) ligand 5 (CCL5), chemokine ligand 11 (CCL11), basic fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon (IFN)-γ, CXCL10, CCL2, CCL3, CCL4, platelet-derived growth factor-BB (PDGF-BB), tumour necrosis factor (TNF) and vascular endothelial growth factor (VEGF).
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Intestinal microbiota composition
Sequencing of fecal samples, Gut Health Panel from Bio-Me, covering 100 different bacterias
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Physical activity
Accelerometer (AX3 Axivity Newcastle, UK), attached to the thigh and worn for 7 consecutive days in the first week of diet A and in the first week of diet B.
Moderate to vigorous physical activity (MVPA) is detected in 5-second intervals. Measuring time (min/day) spent in MVPA during the first week of diet A and during the first week of diet B.
Measured: Immediately after one week of Diet A, and immediately after one week of Diet B
Blood pressure
20 min measurement
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Body composition, metabolic age
Tanita Body Composition Analyzer
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Mitochondrial oxygen consumption rate
SeaHorse, mononuclear cells in peripheral blood
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
ALAS1mRNA
TaqMan gene expression assay
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Urine-ALA/creatinine & urine-porphyrins
level measurement of concentration in urine
Measured: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Mitochondrial function-related genes
Paxgen tubes, qPCR, Mitochondrial genome sequencing
Measured: At baseline immediately before each participants first diet intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start27 Jan 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Porphyria, Acute IntermittentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a crossover study involving 50 individuals with AIP. The study design was chosen to determine whether the treatment has an effect compared to baseline analyses and whether the sequence of treatment has an effect, as well as whether one of the interventions is more effective than the other.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Elin Storjord, MD PhD, Principal investigator, Nordlandssykehuset HFPer Dahlqvist, MD PhD, Principal investigator, Norrland University Hospital, UmeåEliane Sardh, MD PhD, Principal investigator, Studieenheten, Akademiskt Specialistcentrum, Stockholm Läns Sjukvårdsområde, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273644
- Sponsor's protocol ID
- HNF1719-24
- Status last verified
- Aug 2025
- First submitted
- 8 Feb 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Selected Individual participant data that underlie the results reported in published articles, can be accessed upon reasonable request to the principal investigator, but in each case the data will be deidentified, and the data can only be shared if it is considered that it will not be possible to reidentify persons from the data, and if in each case the data protection officer has advised it and the principal investigator has granted it. Due to Norwegian law on sensitive data, raw data of this type cannot be submitted to public repositories, e.g DNA sequencing data. Study protocol and the template for informed consent form is available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment
- ClinicalTrials.gov ID
- NCT06273644
- Acronym / sponsor ID
- HNF1719-24
- Conditions
- Porphyria, Acute Intermittent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- 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
- Study start
- 27 Jan 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute intermittent porphyria (AIP) is an inherited disease that leads to the accumulation of porphobilinogen (PBG), resulting in severe abdominal pain, paralysis, fatigue, low-grade inflammation, and an increased risk of kidney failure and liver cancer. Studies at the cellular level and in mice have shown that elevated levels of glucose and insulin can affect heme synthesis, potentially reducing PBG levels. The investigators have previously demonstrated that individuals with AIP consume less carbohydrate (E% 40) than recommended. The investigators aim to conduct a crossover study involving 50 participants with AIP, where 50% will be subjected to a 4-week intervention with 60-65 E% carbohydrates, while the other half will consume 40-45 E% carbohydrates for 4 weeks. After a 4-week intervention-free period, the two groups will switch to the respective carbohydrate percentages. Symptoms, PBG levels, continuous tissue glucose, plasma/serum insulin, glucose, cytokines, amino acid levels, microbiota in the gut, body composition, and physical activity measured using accelerometers will be assessed before and after each intervention and compared. Mitochondrial activity will be assessed at the cellular level as oxidative activity. Mutations in mitochondrial DNA and RNA will also be examined since defects in oxidative energy metabolism are known to be associated with inflammation and cancer. The work will be carried out at Nordland Hospital and at the University of Oslo. The study will be coordinated and conducted by the Postdoc and partners at Nordland Hospital, Karolinska University Hospital Stockholm and Norrland University Hospital, Umeå, the University of Oslo, the Arctic University of Tromsø, and Nord University. Clinical nutritionists will create dietary plans, and bioengineers will perform analyses. Stay abroad for postdoc, and research cooperation, with porphyria researchers at UTMB, Texas and MGH, Boston, US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a crossover study involving 50 individuals with AIP. The study design was chosen to determine whether the treatment has an effect compared to baseline analyses and whether the sequence of treatment has an effect, as well as whether one of the interventions is more effective than the other.
| Arm | Type | Receives |
|---|---|---|
| 60-65 E% Carbohydrates | Experimental | Other: CarbohydratesDiet plan A with 60-65 E% Carbohydrates in 4 weeks |
| 40-45% Carbohydrates | Active comparator | Other: CarbohydratesDiet plan B with 40-45 E% Carbohydrates in 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of AIP
Key exclusion criteria (5 listed)
- Not having diagnosis of AIP
- Undergoing treatment as part of other clinical research on AIP
- Pregnancy
- Diabetes
- Below 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbohydratesHalf of the patients will initially follow Diet Plan A with 60-65 E% carbohydrates for 4 weeks, followed by a 4-week washout period, and then Diet Plan B with 40-45 E% carbohydrates for 4 weeks. The other half will start with Diet Plan B for 4 weeks, followed by a 4-week washout period, and then Diet Plan A for 4 weeks . Diet Plans A and B contain recommended and adequate nutrients according to the Nordic Nutrition Recommendations 2023 (NNR2023) for maintaining a stable weight. | Other | 40-45% Carbohydrates, 60-65 E% Carbohydrates |
Primary outcome
Change in Urine Porphobilinogen/creatinine
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
AIP biochemical disease activity. First morning Urine Porphobilinogen/creatinine. Change from baseline before diet A to immediately after diet A, and change from baseline before diet B to immediately after diet B
Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements
Time frame: Day 1 ,4, 8, 11, 15, 18, 22, 25 and 29 of Diet Intervention A and of Diet Intervention B
AIP biochemical disease activity, repeated measurements Percentage change in the median of repeated measurements of Urine Porphobilinogen/creatinine concentrations between Diet A and Diet B The repeated measurements in urine analyzed in urine samples from Day 1 ,4, 8, 11, 15, 18, 22, 25 and 29 of Diet A and of Diet B, and calculated median of Urine Porphobilinogen/creatinine concentration for diet A and median for diet B
18 secondary outcomes
Number of Hospitalizations,sick leaves, and doctor visits due to AIP
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Health status
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Plasma Glucose level
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Interstitial fluid glucose level
Time frame: Day 15 and 29 of diet A and day 15 and 29 of diet B
Number of hypoglycemic events
Time frame: Day 15 and 29 of diet A and day 15 and 29 of diet B
Amino acid profile
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Plasma insulin, glucose, c-peptide
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
HOMA score
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
HbA1c
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Cytokines in plasma
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Intestinal microbiota composition
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Physical activity
Time frame: Immediately after one week of Diet A, and immediately after one week of Diet B
Blood pressure
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Body composition, metabolic age
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Mitochondrial oxygen consumption rate
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
ALAS1mRNA
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Urine-ALA/creatinine & urine-porphyrins
Time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B
Mitochondrial function-related genes
Time frame: At baseline immediately before each participants first diet intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Selected Individual participant data that underlie the results reported in published articles, can be accessed upon reasonable request to the principal investigator, but in each case the data will be deidentified, and the data can only be shared if it is considered that it will not be possible to reidentify persons from the data, and if in each case the data protection officer has advised it and the principal investigator has granted it. Due to Norwegian law on sensitive data, raw data of this type cannot be submitted to public repositories, e.g DNA sequencing data. Study protocol and the template for informed consent form is available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elin Storjord, MD PhD principal investigator
Nordlandssykehuset HF
Per Dahlqvist, MD PhD principal investigator
Norrland University Hospital, Umeå
Eliane Sardh, MD PhD principal investigator
Studieenheten, Akademiskt Specialistcentrum, Stockholm Läns Sjukvårdsområde, Region Stockholm
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrates in people with Porphyria, Acute Intermittent, run by Nordlandssykehuset HF at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elin Storjord, MD PhD (97072484, elin.storjord@nordlandssykehuset.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urine Porphobilinogen/creatinine (time frame: Baseline before diet A and immediately after the 4 weeks of diet A, baseline before diet B and immediately after the 4 weeks of diet B). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.