Amorphous Calcium Carbonate (Acc) Versus Crystalline Calcium Carbonate (Ccc) Using Stable Calcium Isotopes In Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT01338142|
Recruitment Status : Unknown
Verified March 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Postmenopause||Other: CCC Other: ACC||Phase 1 Phase 2|
This is a randomized, double-blind, crossover bioavailability study comparing the fractional absorption of calcium from amorphous calcium carbonate (ACC) versus crystalline calcium carbonate (CCC) using stable calcium isotopes in postmenopausal women.
The study is comprised of 15 subjects orally administered immediately after breakfast a 600 mg gelatin capsules containing either 600 mg (2 capsules of 300 mg)of ACC (192 mg elemental calcium) of 480 mg CCC (192 mg elemental calcium), labeled with 15 mg of 44Ca (2 capsules of 300 mg).
Five minutes following the oral administration, each subject will be infused intravenously with 1.5 mg of CaCl2 labeled with 42Ca over 10 min. Over the following 24 h subjects will consume meals that will be selected by the Unit of Clinical Nutrition at Sourasky Medical Center nutritionist on the basis of their food diary and ALL urine excreted during this time should be collected in a designated urine container and returned to the Unit of Clinical Nutrition at Sourasky Medical Center for evaluation. The same protocol as in day 0 with a crossover oral treatment will be performed after 21 day washout period.
Dosing day will be designated "Day 0". Eligible subjects are randomly assigned to one of the study treatments according to the following regimens:
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomised, Double-Blind, Crossover Bioavailability Study Comparing Amorphous Calcium Carbonate (Acc) Versus Crystalline Calcium Carbonate (Ccc) Using Stable Calcium Isotopes In Postmenopausal Women|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||July 2012|
Placebo Comparator: CCC
Crystalline calcium carbonate (CCC)
600 mg (2 capsules of 300 mg) for oral use of 480 mg CCC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca and 120 mg of inactive filler, sucrose.
1.5 mg of 42Ca labeled CaCl2 through IV injection
Amorphous calcium carbonate (ACC)
600 mg (2 capsules of 300 mg) for oral use containing 600 mg ACC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca 1.5 mg of 42Ca labeled CaCl2 through IV injection
- Mean change in fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs. crystalline calcium carbonate (CCC). [ Time Frame: 1 year ]Fractional absorption will be evaluated by measuring 42Ca and 44Ca levels in the urine over 24 hours (the ratio)
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 ClinicalTrials.gov identifier (NCT number): NCT01338142
|Contact: Nachum Vaisman, Professorfirstname.lastname@example.org|
|Tel Aviv Medical Center||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Nachum Vaisman, Professor 00-972-3-6974807 email@example.com|