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Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications

NCT01000233 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2010-05-26

No results posted yet for this study

Summary

Intervention study focused on preventing the progression of aortic valve calcification.

Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the severe calcified aortic stenosis and coronary calcification.

Its increasing prevalence is now a health problem. The knowledge and the therapeutic objective of this condition have changed in recent years and pathophysiological aspects at present, focus on atherosclerotic disease and inflammation.

Several clinical trials have failed to demonstrate that statins or ACE inhibitors prevent the progression of cardiovascular calcification.

Taking into account the new concepts of ectopic calcification and research results from our group, the most logical approach to prevent progression would be an early intervention and management of the calcification inhibiting agents such as phytate (inositol six-phosphate -- InsP6).

Hypothesis: The phytate prevents or delays the progression of cardiovascular calcification.

It is a clinical trial of intervention of oral phytate (InsP6) in patients with mild to moderate cardiovascular calcification (aortic valve and / or coronary arteries) compared with placebo over a period of 24 months.

It is a prospective, randomized minimization of variables to ensure homogeneity of the groups.

The primary analysis will be the time evolution of the extent of calcium in the aortic valve and coronary arteries made with CT.

Secondary variables are the degree of progression of aortic stenosis and clinical events (death, stroke, angina, stroke and cancer of any type).

Conditions

  • Heart Valve Disease
  • Aortic Stenosis

Interventions

DIETARY_SUPPLEMENT

Phytine (phytate)

300 mg tid \* 24 months

DIETARY_SUPPLEMENT

Placebo

Phytine (Phytate)

Sponsors & Collaborators

  • Laboratorios BIOMED SA

    collaborator UNKNOWN

  • Hospital Universitari Son Dureta

    lead OTHER

Principal Investigators

  • Guillem Frontera, MD · Hospital Universitario Son Dureta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-03-31
Completion
2012-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01000233 on ClinicalTrials.gov