HyperferritinemiaNCT02526121
Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia
A study testing Phlebotomy and Dietary and lifestyle counseling. in people with Hyperferritinemia and Hypertriglyceridemia, run by Instituto Aragones de Ciencias de la Salud at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperferritinemia, Hypertriglyceridemia
- What is being tested?
- Phlebotomy and Dietary and lifestyle counseling.
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Dec 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperferritinemia: > 300µgr/L for male and >200µgr/L for female.
- Hypertriglyceridemia: > 200 mg/dL in two determinations after at least ten hours of fasting and lipid-lowering diet.
Who cannot join
- Contraindications for phlebotomy: poor venous access, previous intolerance (hypotension or apprehension), heart disease, anemia.
- Subjects suffering from acute or chronic disease, including liver disease, diabetes, cancer, kidney disease or uncontrolled thyroid disease.
- Elevated C reactive protein (CRP) as a parameter of inflammation (>10mg/L).
- Alcohol intake: over 30 gr. per day for men and 25 gr. per day for women.
- Lipid lowering drugs use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia.
The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone.
All subjects in this study will follow dietary and lifestyle counseling in a period of 3 months.
A randomized group will receive phlebotomies every 3 weeks in this period.
- Conditions
- Hyperferritinemia, Hypertriglyceridemia
- Being tested
- Phlebotomy, Dietary and lifestyle counseling.
- Medical subject headings
- Hyperferritinemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyProcedure or surgery
Volume of 400 mL every 3 weeks, 3 times.
Dietary and lifestyle counseling.Behavioural
Dietary and lifestyle counseling.
| Study group | Role | What they receive |
|---|---|---|
| Phlebotomy associated with dietary and lifestyle counseling | Experimental | Not described Receives: Procedure: Phlebotomy; Behavioral: Dietary and lifestyle counseling. |
| Dietary and lifestyle counseling. | Active comparator | Not described Receives: Behavioral: Dietary and lifestyle counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides concentration
Measured: Three months before
Secondary outcomes (1)
Iron parameters
Ferritin level: >300 µgr/L in men and >200 µgr/L in women
Measured: Three months before
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperferritinemiaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Aragones de Ciencias de la Salud
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Civeira, Instituto Aragones de Ciencias de la Salud
- Investigators
- Fernando Civeira, MD, PhD, Principal investigator, Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526121
- Sponsor's protocol ID
- CEICA;PI10/099
- Status last verified
- Aug 2016
- First submitted
- 25 Mar 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Mateo-Gallego R, Lacalle L, Perez-Calahorra S, Marco-Benedi V, Recasens V, Padron N, Lamiquiz-Moneo I, Baila-Rueda L, Jarauta E, Calmarza P, Cenarro A, Civeira F. Efficacy of repeated phlebotomies in hypertriglyceridemia and iron overload: A prospective, randomized, controlled trial. J Clin Lipidol. 2018 Sep-Oct;12(5):1190-1198. doi: 10.1016/j.jacl.2018.06.017. Epub 2018 Jul 4.
PubMed 30049591
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia.
- ClinicalTrials.gov ID
- NCT02526121
- Acronym / sponsor ID
- CEICA;PI10/099
- Conditions
- Hyperferritinemia, Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto Aragones de Ciencias de la SaludOther government
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Aug 2015 (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 this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone.
All subjects in this study will follow dietary and lifestyle counseling in a period of 3 months.
A randomized group will receive phlebotomies every 3 weeks in this period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phlebotomy associated with dietary and lifestyle counseling | Experimental | Procedure: Phlebotomy, Behavioral: Dietary and lifestyle counseling. |
| Dietary and lifestyle counseling. | Active comparator | Behavioral: Dietary and lifestyle counseling. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hyperferritinemia: > 300µgr/L for male and >200µgr/L for female.
- Hypertriglyceridemia: > 200 mg/dL in two determinations after at least ten hours of fasting and lipid-lowering diet.
Key exclusion criteria (5 listed)
- Contraindications for phlebotomy: poor venous access, previous intolerance (hypotension or apprehension), heart disease, anemia.
- Subjects suffering from acute or chronic disease, including liver disease, diabetes, cancer, kidney disease or uncontrolled thyroid disease.
- Elevated C reactive protein (CRP) as a parameter of inflammation (>10mg/L).
- Alcohol intake: over 30 gr. per day for men and 25 gr. per day for women.
- Lipid lowering drugs use.
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 |
|---|---|---|
| PhlebotomyVolume of 400 mL every 3 weeks, 3 times. | Procedure or surgery | Phlebotomy associated with dietary and lifestyle counseling |
| Dietary and lifestyle counseling.Dietary and lifestyle counseling. | Behavioural | Dietary and lifestyle counseling., Phlebotomy associated with dietary and lifestyle counseling |
Primary outcome
Triglycerides concentration
Time frame: Three months before
1 secondary outcome
Iron parameters
Time frame: Three months before
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Derived from this study: PubMed 30049591Mateo-Gallego R, Lacalle L, Perez-Calahorra S, Marco-Benedi V, Recasens V, Padron N, Lamiquiz-Moneo I, Baila-Rueda L, Jarauta E, Calmarza P, Cenarro A, Civeira F. Efficacy of repeated phlebotomies in hypertriglyceridemia and iron overload: A prospective, randomized, controlled trial. J Clin Lipidol. 2018 Sep-Oct;12(5):1190-1198. doi: 10.1016/j.jacl.2018.06.017. Epub 2018 Jul 4.
- Individual participant dataSharing planned: Yes
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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.
Fernando Civeira, MD, PhD principal investigator
Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phlebotomy and Dietary and lifestyle counseling. in people with Hyperferritinemia and Hypertriglyceridemia, run by Instituto Aragones de Ciencias de la Salud at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 30 Aug 2016. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides concentration (time frame: Three months before). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526121, which also lists 1 linked publication.
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 30 Aug 2016.