Clinical trials

Clinical Trial in Postmenopausal Women

Amorphical conducted a double-blinded, randomized, crossover interventional study to compare the bioavailability of ACC with that of CCC using the dual stable isotope technique.

The study was conducted in Tel Aviv Sourasky Medical Center, Israel.

The study population included 15 early postmenopausal women around age of 55 years with no history of major medical illness or metabolic bone disorder, excess calcium intake, or vitamin D deficiency.

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 study demonstrated the superior gastrointestinal bioavailability of synthetic amorphous calcium carbonate versus the crystalline form of calcium carbonate.

References

“A Randomized, Double-Blind, Crossover Bioavailability Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium Carbonate (CCC) Using Stable Calcium Isotopes In Postmenopausal Women”; ClinicalTrials.gov Identifier: NCT01338142; Study Principal Investigator: Prof. N. Vaisman, Ichilov Hospital, Tel Aviv, Israel.

https://clinicaltrials.gov/ct2/show/NCT01338142?term=Amorphical&cntry=IL&draw=2&rank=3

Published in the following article:

“Increased calcium absorption from synthetic stable amorphous calcium carbonate: double-blind randomized crossover clinical trial in postmenopausal women”, Vaisman N, Shaltiel G, Daniely M, Meiron OE, Shechter A, Abrams SA, Niv E, Shapira Y, Sagi A., J Bone Miner Res. 2014;29(10):2203-9.

“Bone loss prevention in ovariectomized rats using stable amorphous calcium carbonate”Shaltiel, G., Bar-David, E., Meiron, O.E., Waltman, E., Shechter, A., Aflalo, E.D., Stepensky, D., Berman, A., Martin, B.R. & Weaver, C.M, Health 5, 18-29 (2013). Health

http://dx.doi.org/10.4236/health.2013.57A2003

3 “Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium Substance (CCS) in Hypoparathyroidism Patients”. ClinicalTrials.gov Identifier: NCT01815021; Study Principal Investigator: Prof. S. Ish-Shalom, Ramban Hospital, Haifa, Israel.

https://clinicaltrials.gov/ct2/show/NCT01815021?term=Amorphical&cntry=IL&draw=2&rank=1

4 “Improving Function, Welfare of Late-stage Cancer Subjects by ACC”; ClinicalTrials.gov Identifier: NCT03057314; Study Principal Investigator: Prof. M Gotfried, Meir Hospital, Kfar Saba, Israel

https://clinicaltrials.gov/ct2/show/NCT03057314?term=Amorphical&cntry=IL&draw=2&rank=5

“Effect of Amorphous Calcium Carbonate (ACC) Treatment on Function and Welfare Improvement in Late-stage Solid Cancer Subjects (With or Without Lung Involvement)”; ClinicalTrials.gov Identifier: NCT03582280; Study Principal Investigator: Prof. N. Hovav, Hadassah Hospital, Jerusalem, Israel

https://clinicaltrials.gov/ct2/show/NCT03582280?term=Amorphical&cntry=IL&draw=2&rank=4

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