NCT02526121

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

March 25, 2015

Last Update Submit

August 29, 2016

Conditions

HyperferritinemiaHypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Triglycerides concentration

    Three months before

Secondary Outcomes (1)

  • Iron parameters

    Three months before

Other Outcomes (8)

  • Total cholesterol

    Three months before

  • HDL-cholesterol

    Three months before

  • LDL- cholesterol

    Three months before

  • +5 more other outcomes

Study Arms (2)

Phlebotomy associated with dietary and lifestyle counseling

EXPERIMENTAL
Procedure: PhlebotomyBehavioral: Dietary and lifestyle counseling.

Dietary and lifestyle counseling.

ACTIVE COMPARATOR
Behavioral: Dietary and lifestyle counseling.

Interventions

PhlebotomyPROCEDURE

Volume of 400 mL every 3 weeks, 3 times.

Phlebotomy associated with dietary and lifestyle counseling
Dietary and lifestyle counseling.BEHAVIORAL

Dietary and lifestyle counseling.

Dietary and lifestyle counseling.Phlebotomy associated with dietary and lifestyle counseling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30049591DERIVED

MeSH Terms

Conditions

HyperferritinemiaHypertriglyceridemia

Interventions

PhlebotomyDiet

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Fernando Civeira, MD, PhD

    Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2015

First Posted

August 18, 2015

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

ES(1)