COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000233
Recruitment Status : Unknown
Verified May 2010 by Hospital Universitari Son Dureta.
Recruitment status was:  Recruiting
First Posted : October 23, 2009
Last Update Posted : May 26, 2010
Laboratorios BIOMED SA
Information provided by:
Hospital Universitari Son Dureta

Brief 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).

Condition or disease Intervention/treatment Phase
Heart Valve Disease Aortic Stenosis Dietary Supplement: Phytine (phytate) Dietary Supplement: Placebo Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications
Study Start Date : August 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
Drug Information available for: Inositol

Arm Intervention/treatment
Active Comparator: Phytine (Phytate)
300 mg tid* 24 months
Dietary Supplement: Phytine (phytate)
300 mg tid * 24 months
Other Names:
  • Inositol hexaphosphate

Dietary Supplement: Placebo
Phytine (Phytate)
Other Names:
  • Inositol hexaphosphate

Placebo Comparator: Placebo Dietary Supplement: Placebo
Phytine (Phytate)
Other Names:
  • Inositol hexaphosphate

Primary Outcome Measures :
  1. Calcium in aortic valve and in coronary arteries assessed by multidetector CT scanner (Agatston units) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Clinical events. A composite event is considered: death, hospitalization for angina, coronary revascularization (surgical or percutaneous), valvular surgery, nonfatal myocardial infarction and stroke. [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Calcium in the aortic valve, characterized by Rosenhek score grade 2 or 3 in echocardiography and / or with not severe coronary calcification detected in other studies (angiography, CT).

Exclusion criteria:

  • Severe aortic (Rosenhek 4)or coronary calcification .
  • Positive pregnancy test (if pregnancy occurs during the study be deferred final evaluation at the end of gestation, if the patient wishes to continue in the study).
  • Addiction to drugs or alcohol.
  • Renal insufficiency (serum creatinine> 2mg/dl).
  • Liver disease or cirrhosis.
  • Severe valve disease or requiring surgery during the study.
  • Unstable ischemic heart disease (revascularization in the last 3 months).
  • Atrial fibrillation in the initial evaluation (difficulty in measuring Ca). May be included later if sinus rhythm is achieved stable for at least three months.
  • The need for any medication in relation to calcium metabolism (PTH, bisphosphonates, strontium ranelate, raloxifene, oral calcium, vitamin D, calcitonin, etc.).
  • Participation in another trial in the three months prior to evaluation.
  • Suspected difficulties to accomplish during the two years, for any reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01000233

Layout table for location contacts
Contact: Guillem Frontera, MD +34971175334
Contact: Carlos Fernandez_Palomeque, MD +34971175504

Layout table for location information
Hospital Universitario Son Dureta Recruiting
Palma, Balearic Islands, Spain, 07014
Contact: Carlos Fernandez-Palomeque, MD    +34971175504   
Principal Investigator: Carlos Fernandez-Palomeque, MD         
Sub-Investigator: Guillem Frontera, MD         
Sub-Investigator: Grases Felix, PhD         
Sub-Investigator: Bethencourt Armando, Phd MD         
Sub-Investigator: Joan Alguersuary, MD         
Sub-Investigator: Josep Francesc Forteza, PhD MD         
Sub-Investigator: Andres Grau, MD         
Sub-Investigator: Jose Ignacio Saez de Ibarra, MD         
Sub-Investigator: Rosa Gonzalez, MD         
Sub-Investigator: Rafael Prieto, PhD MD         
Sub-Investigator: Antonia Costa, PhD         
Sub-Investigator: Onofre Caldes, MD         
Sponsors and Collaborators
Hospital Universitari Son Dureta
Laboratorios BIOMED SA
Layout table for investigator information
Study Chair: Guillem Frontera, MD Hospital Universitario Son Dureta
Layout table for additonal information
Responsible Party: Carlos Fernandez-Palomeque, Hospital Universitari Son Dureta Identifier: NCT01000233    
Other Study ID Numbers: FIS_PI081931
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010
Keywords provided by Hospital Universitari Son Dureta:
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs