Double-blind, randomised trial shows positive results for SinoVeda\'s EffectiCal
EffectiCal equally effective as Caltrate in measurements of bone formation and bone resorption and has fewer side effects, finds study
SinoVeda Canada reports positive clinical results for EffectiCal from its 24-week double-blind, randomised comparative clinical trial in post-menopausal women.
The results showed that the Edmonton-based company's EffectiCal, a supplement containing 300mg of calcium, was equally as effective as Pfizer's Caltrate (600mg calcium) and vitamin D(3) in measurements of bone formation and bone resorption. Additionally, those women who received EffectiCal had fewer gastrointestinal side effects than those taking Caltrate.
A total of 97 subjects were randomised to two groups; one received EffectiCal, and the other Caltrate and vitamin D(3). Subjects in both groups received active treatment once daily for 24 weeks. The primary endpoints were to evaluate the comparative effects of EffectiCal and Caltrate/vitamin D(3) 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 groups for both CTx and PINP.
Evaluation of the secondary endpoints revealed a significant improvement in the constipation profile of subjects receiving EffectiCal compared with 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 (p0.001), less abdominal pain (p0.001), less bother by gas (p0.001) and less lack of appetite (p0.001). EffectiCal subjects also achieved a significantly higher increase in 25D levels compared with Caltrate/vitamin D(3) (p=0.003). No statistical difference in PTH levels was seen between groups.
'EffectiCal is a compelling supplementation option for individuals concerned about bone loss and osteoporosis. Compared with Caltrate, EffectiCal is a very dose-efficient product and has a very benign side effect profile,' said Richard Fedorak, Principal Investigator and Professor of Medicine at the University of Alberta.
Yun Tam, President, Chief Scientific Officer, and Co-founder of SinoVeda Canada, said: '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.'
