EDMONTON, May 21, 2014 /CNW/ - SinoVeda Canada Inc. today announces positive clinical results for EffectiCal® from its 24-week double-blind, randomized comparative clinical trial in post-menopausal women. The results showed that EffectiCal®, a supplement containing 300mg of calcium, was equally as effective as Caltrate® (600mg calcium) and vitamin D3 in measurements of bone formation and bone resorption. Additionally, subjects in this study who received EffectiCal® had significantly fewer gastrointestinal side effects than those taking Caltrate®.
"EffectiCal® is a compelling supplementation option for individuals concerned about bone loss and osteoporosis. Compared to Caltrate®, EffectiCal® is a very dose-efficient product and has a very benign side effect profile," stated Dr. Richard Fedorak, Principal Investigator and Professor of Medicine at the University of Alberta.
Dr. Yun Tam, President, Chief Scientific Officer, and Co-founder of SinoVeda Canada Inc. stated, "We are extremely pleased with the clinical validation of EffectiCal®'s benefits. While we had long predicted these benefits based on our scientific know-how and rigorous laboratory testing, it is nice to see our predictions translated so cleanly into the clinic."
Clinical Trial Details
The clinical trial was a double-blind, randomized comparative study designed to assess the comparative efficacy and safety of EffectiCal® versus Caltrate® and vitamin D3 (cholecalciferol) in postmenopausal women. A total of 97 subjects were randomized to two arms; one arm received EffectiCal®, and the other received Caltrate® and vitamin D3. Subjects in both arms received active treatment once daily for 24 weeks. The primary endpoints were to evaluate the comparative effects of EffectiCal® and Caltrate® / vitamin D3 on C-telopeptide of type I collagen (CTx), a biomarker for bone resorption, and N-terminal propeptide of type I collagen (PINP), a biomarker for bone formation. Secondary endpoints included an assessment of constipation profiles, parathyroid hormone (PTH), and 25-hydroxyvitamin D (25D) levels.
The average age of subjects was 60 years and there were no demographic differences or health risk factor differences between groups at baseline. Evaluation of the primary endpoints showed no significant difference between arms for both CTx and PINP.
Evaluation of the secondary endpoints revealed a significant improvement in the constipation profile of subjects receiving EffectiCal® compared to those receiving Caltrate®, including enhanced ability to fully empty bowels for each bowel movement (p=0.01), less constipated fecal profile as defined by the Bristol stool scale (p<0.001), less abdominal pain (p<0.001), less bother by gas (p<0.001) and less lack of appetite (p<0.001). EffectiCal® subjects also achieved a significantly higher increase in 25D levels compared to Caltrate® / vitamin D3 (p=0.003). No statistical difference in PTH levels was seen between arms.
Caltrate® is a registered trademark of Pfizer, Inc.
EffectiCal® is a patented new form of multi-element calcium product for the maintenance of bone health and reducing the risk of developing osteoporosis. EffectiCal® is engineered to be more soluble in the intestine and provide more useable calcium per dose, compared to existing calcium products. Since zinc and magnesium are often depleted in patients with low calcium intake, EffectiCal® is supplemented with additional zinc and magnesium to maintain stable levels in the body.
Osteoporosis is a medical condition characterized by low bone density and deterioration of bone tissue. As the bones weaken over time, patients are at increased risk of bone fracture, its associated morbidities and mortality. Individuals at risk for osteoporosis include those that are sedentary, have low calcium intake, and the elderly, particularly post-menopausal women.
SinoVeda Canada Inc. is a privately held Edmonton-based health science company that uses botanical sources to develop and commercialize nutritional food ingredients, pharmaceutical-grade consumer health products, and prescription medicines. SinoVeda's patented Pharmaceutical Platform Technology® (PPT) allows the company to isolate, quantify, and standardize the active, absorbable ingredients from botanical sources, enabling the production of unique multiple-active, multiple-target, and patentable products. The first pharmaceutical candidate derived from PPT is SCI-RC-1341, currently in research for the treatment of hot flashes and osteoporosis. In the near-term, SinoVeda's consumer health portfolio includes:
- EffectiCal®, a highly soluble multi-element calcium supplement for the maintenance of bone health and reducing the risk of developing osteoporosis
- ProFlexaTM, a botanically-based topical cream to relieve muscle and joint aches and pain
- LorechoTM, an all-natural product to support cardiovascular health and LDL cholesterol balance
SOURCE: SinoVeda Canada Inc.
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