TRIALS: The Children's Hospital at Westmead, NSW
In Australia, our main source of vitamin D3 comes from sunlight exposure. Despite the fact that we live in a sunburnt country, vitamin D3 deficiency is becoming a significant problem nationwide. Increasingly, we are discovering that many Australians are not receiving adequate vitamin D from casual sun exposure.
In children, vitamin D3 deficiency affects bone mass and, in the long-term, leads to rickets (soft bones). With the incidence of vitamin D3 deficiency in Australian children increasing, physicians are beginning to question what dosage form would be most suitable for these young patients.
The Paediatric Medicines Advisory Group in Australia has recognised a need for high dose vitamin D3 in a liquid form to treat vitamin D3 deficiency in children. The development of a vitamin D3 liquid that is both high-dose and palatable for children has taken some time to perfect. Previous products were unstable, had a short shelf-life and were unappetising; leading to patient non-compliance. With the advancement of a patent-pending process in liquid vitamin D3 manufacturing, BioCeuticals® has been able to produce a highly stable and pleasant-tasting D3 liquid which now comes in two dosage strengths: D3 Drops providing 333.3IU per drop, and D3 Drops Forte providing 1000IU per drop.
Dr Craig Munns is a paediatric endocrinologist conducting research at The Children’s Hospital at Westmead, NSW, to determine if periodic, supraphysiologic doses of vitamin D (STOSS Therapy; 100,000IU/week for 4 weeks) is necessarily better than long-term, lower doses of vitamin D (e.g. 5000IU daily for 80 days) to treat vitamin D deficiency in children and adolescents. BioCeuticals® is supplying the patent-pending vitamin D3 emulsions for this trial. BioCeuticals® D3 Drops (333.3IU per dose) are also being used in a second trial conducted by Dr Craig Munns at The Children’s Hospital at Westmead, NSW. This study investigates the impact of zoledronic acid and vitamin D3 therapy in Perthes disease – a devastating degenerative bone disease that affects the hip joint in children.