SinoVeda Canada Inc. 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 300 mg of calcium, was equally as effective as Caltrate® (600 mg 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.