This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Hospital Universitari Son Dureta.
Recruitment status was:  Recruiting
Laboratorios BIOMED SA
Information provided by:
Hospital Universitari Son Dureta Identifier:
First received: October 22, 2009
Last updated: May 25, 2010
Last verified: May 2010

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 Intervention Phase
Heart Valve Disease Aortic Stenosis Dietary Supplement: Phytine (phytate) Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hospital Universitari Son Dureta:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: August 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01000233

Contact: Guillem Frontera, MD +34971175334
Contact: Carlos Fernandez_Palomeque, MD +34971175504

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
Study Chair: Guillem Frontera, MD Hospital Universitario Son Dureta
  More Information

Responsible Party: Carlos Fernandez-Palomeque, Hospital Universitari Son Dureta Identifier: NCT01000233     History of Changes
Other Study ID Numbers: FIS_PI081931
Study First Received: October 22, 2009
Last Updated: May 25, 2010

Keywords provided by Hospital Universitari Son Dureta:

Additional relevant 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 processed this record on September 20, 2017