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Title: Increased calcium absorption from synthetic stable amorphous calcium carbonate: Double-blind randomized crossover clinical trial in post-menopausal women

Author
item VAISMAN, NACHUM - Tel-Aviv Sourasky Medical Center
item SHALTIEL, GALIT - Amorphical, Ltd
item DANIELY, MICHAL - Amorphical, Ltd
item MEIRON, OREN - Amorphical, Ltd
item SHECHTER, ASSAF - Amorphical, Ltd
item ABRAMS, STEVEN - Children'S Nutrition Research Center (CNRC)
item NIV, EVA - Tel-Aviv Sourasky Medical Center
item SHAPIRA, YAMI - Tel-Aviv Sourasky Medical Center
item SAGI, AMIR - Ben Gurion University Of Negev

Submitted to: Journal of Bone and Mineral Research
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 4/2/2014
Publication Date: 10/1/2014
Citation: Vaisman, N., Shaltiel, G., Daniely, M., Meiron, O.E., Shechter, A., Abrams, S.A., Niv, E., Shapira, Y., Sagi, A. 2014. Increased calcium absorption from synthetic stable amorphous calcium carbonate: Double-blind randomized crossover clinical trial in post-menopausal women. Journal of Bone and Mineral Research. 29(10):2203-2209.

Interpretive Summary: Calcium supplementation is often used as a way of achieving adequate calcium intake. We designed this research study to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (CCC) using the dual stable isotope technique. This study was conducted in adults but the results would also be important and relevant to children. A regular breakfast was followed by randomly provided CCC or ACC capsules and measuring calcium absorption with stable, non-radioactive tracers of calcium. The results indicated that FCA of ACC was doubled (on average compared to that of CCC). The higher absorption of the synthetic stable ACC may serve as a better way of calcium supplementation.

Technical Abstract: Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (CCC) using the dual stable isotope technique. The study was conducted in the Unit of Clinical Nutrition, Tel Aviv Sourasky Medical Center, Israel. The study population included 15 early postmenopausal women aged 54.9 +/- 2.8 (mean +/- SD) years with no history of major medical illness or metabolic bone disorder, excess calcium intake, or vitamin D deficiency. Standardized breakfast was followed by randomly provided CCC or ACC capsules containing 192 mg elemental calcium labeled with (44) Ca at intervals of at least 3 weeks. After swallowing the capsules, intravenous CaCl2 labeled with (42) Ca on was administered on each occasion. Fractional calcium absorption (FCA) of ACC and CCC was calculated from the 24-hour urine collection following calcium administration. The results indicated that FCA of ACC was doubled (+/- 0.96 SD) on average compared to that of CCC (p < 0.02). The higher absorption of the synthetic stable ACC may serve as a more efficacious way of calcium supplementation.