Erythropoietic ProtoporphyriaNCT00206869
Does Exercise and Heat Increase the Lightsensibility in Patients With Erythropoietic Protoporphyria
A study testing exercise, heat and red light illumination in people with Erythropoietic Protoporphyria, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to evaluate the effect of exercise and heat on the light sensibility of patients with erythropoietic protoporphyria Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Erythropoietic Protoporphyria
- What is being tested?
- exercise, heat and red light illumination
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Jan 2003to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 70 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Not able to exercise
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, Copenhagen NV, 2400
Hans C Wulf, MD, Sci, +45 35313155, HCW01@bbh.hosp.dk
About this study
The purpose of the study is to evaluate the effect of exercise and heat on the light sensibility of patients with erythropoietic protoporphyria
- Conditions
- Erythropoietic Protoporphyria
- Being tested
- exercise, heat, red light illumination
- Medical subject headings
- Protoporphyria, Erythropoietic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
heatBehavioural
red light illuminationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythropoietic ProtoporphyriaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hans C Wulf, MD, Sci, Study director, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206869
- Sponsor's protocol ID
- KF 01-169/02
- Status last verified
- Dec 2002
- First submitted
- 12 Sep 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Exercise and Heat Increase the Lightsensibility in Patients With Erythropoietic Protoporphyria
- ClinicalTrials.gov ID
- NCT00206869
- Acronym / sponsor ID
- KF 01-169/02
- Conditions
- Erythropoietic Protoporphyria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 21 Sep 2005 (estimated)
- 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 purpose of the study is to evaluate the effect of exercise and heat on the light sensibility of patients with erythropoietic protoporphyria
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Not able to exercise
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 |
|---|---|---|
| exercise | Behavioural | – |
| heat | Behavioural | – |
| red light illumination | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
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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. This study is not recruiting at the moment.
Hans C Wulf, MD, Sci study director
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise, heat and red light illumination in people with Erythropoietic Protoporphyria, run by Bispebjerg Hospital at 1 site in Denmark.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans C Wulf, MD, Sci (+45 35313155, HCW01@bbh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Oct 2006.