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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02526121
Other study ID # CEICA;PI10/099
Secondary ID
Status Completed
Phase N/A
First received March 25, 2015
Last updated August 29, 2016
Start date April 2013
Est. completion date December 2015

Study information

Verified date August 2016
Source Instituto Aragones de Ciencias de la Salud
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Phlebotomy
Volume of 400 mL every 3 weeks, 3 times.
Behavioral:
Dietary and lifestyle counseling.
Dietary and lifestyle counseling.

Locations

Country Name City State
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Instituto Aragones de Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Total cholesterol Three months before Yes
Other HDL-cholesterol Three months before Yes
Other LDL- cholesterol Three months before Yes
Other Apolipoprotein A1 Three months before Yes
Other Apolipoprotein B Three months before Yes
Other Peripheral Insulin resistance measured by HOMA Three months before Yes
Other Inflammatory cytokines Three months before Yes
Other C Reactive Protein Three months before Yes
Primary Triglycerides concentration Three months before Yes
Secondary Iron parameters Ferritin level: >300 µgr/L in men and >200 µgr/L in women Three months before Yes
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