Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss
Status:
Completed
Trial end date:
2014-05-02
Target enrollment:
Participant gender:
Summary
Postmenopausal osteoporosis is one of the important medical disorders affecting women after
menopause. It is characterized by bone loss and reduced bone strength. In turn, this leads to
increased risk of fracture. Bone loss in postmenopausal women occurs when calcium leaks out
of the bones. Supplementing calcium and vitamin D is considered as standard prophylactic
measures against osteoporosis for postmenopausal women over age 50.
Currently, various formulations of calcium salt are under development for the effective
supplementation of calcium. Pearlium/Effecti-Cal is a new formulation optimized for high
solubility of calcium salt. Formulation A5 (the base formulation of Pearlium/Effecti-Cal)
showed three fold higher retention of calcium in rats than calcium carbonate (the most
popular calcium supplement). High retention of calcium allowed the reduction of orally
administered calcium for the same effect. This can contribute to the reduction of
gastrointestinal side effects such as constipation.
In postmenopausal women, bone mineral loss is reflected on the elevated level of bone
turnover markers. In this study, the efficacy of Pearlium/Effecti-Cal will be assessed by the
suppression of bone turnover markers. In addition, the safety of Pearlium/Effecti-Cal will be
evaluated with a bowel function diary, which can capture the profile of constipation
symptoms.
The participants will experience run-in period (two months) for removing the residual effect
of previously taken health product on bone turnover. For the following treatment period (six
months), one hundred and two participants will be allocated by chance into groups for the
treatment of Pearlium/Effecti-Cal or active comparator (conventional calcium supplement).
Phase:
Phase 4
Details
Lead Sponsor:
University of Alberta
Treatments:
Calcium Calcium Carbonate Cholecalciferol Vitamin D