“What is holding us back is a lack of clinical trials,” Bischoff-Ferrari told NutraIngredients after meetings last week in Lyon and Brussels that highlighted micronutrient deficiencies in Europe and elsewhere, with vitamin D featuring prominently.
Vitamin D is most commonly linked with bone health but research has shown it can benefit immunity, cancer and heart health and figures quoted at last week’s meetings highlighted its ability to save €187bn in healthcare costs if deficiencies in 17 European countries could be addressed.
“The problem is vitamin D has limited Intellectual Property (IP) potential, it is a pure public health intervention,” Bischoff-Ferrari said. “There needs to be more double blind, randomised clinical trials but we lack these because it is difficult to gain corporate interest.”
Hopes are being pinned to the 7th European Commission Framework which funds research and technological development projects.
Vital
A proposal for a large European trial of over 70-year-olds with bone fracture, cardiovascular, functional disability, immunity and cognitive endpoints had been proposed by a consortium around Bischoff-Ferrari that would bridge to a similar National Institutes of Health (NIH)-sponsored, 20,000+ subject trial (called Vital) underway in the US.
That trial will test two of the three interventions proposed in the European trial for major cardiovascular and cancer endpoints, albeit with younger subjects (over 60s).
“You need to collaborate to save money and you need the large numbers to have that level of statistical power so that we can find the definite answer,” Bischoff-Ferrari relayed.
She said the EC was due to respond next month to the proposal that sought to track over 2000 seniors who would be closely monitored to test the benefit of three simple nutrition and exercise-based public health strategies, one of them being vitamin D.
A leading ingredient supplier had agreed to supply the vitamin D that will be tested free of charge, but the company was not able to fund the whole trial, which would cost about €13m.
Lobbying
While interested parties waited on the EC decision, Bischoff-Ferrari said events like those held last week were vital because they helped spread the message about the damage being done to public health due to vitamin D deficiencies – coupled with ignorance of the problem.
It also brought academia face-to-face with industry, regulators and government officials.
“You just hope the message reaches the people that make decisions,” she said. “There are many compelling reasons to take measures to increase vitamin D consumption but it comes down to select panels that make such decisions.”
“Meetings like last week are important because it makes parties realise in many cases they are seeking the same goals and that it needs different stakeholders to push forward the agenda. We were pleased with it because the ‘call to action’ message was very clear.”
“And from a research point of view we got to emphasise that it is not like pharma research, that this kind of research needs support from many sources.”
Call to action
Those signing up to the 'call to action' included DSM, Kraft Foods, Unilever, GAIN (Global Alliance for Improved Nutrition), the International Genetic Alliance and the International Osteoporosis Foundation.
They “urged” European health ministers to:
· Implement campaigns to raise awareness of the importance of micronutrients in the diet
· Ensure that health professionals fully understand the consequences of micronutrient deficiency
· Promote research in the field of nutrition
· Provide fact-based information on the role of micronutrients in minimising disease burden and saving on healthcare costs
· Ensure health professionals can offer effective nutrition care programs to patients.
D background
Vitamin D refers to two biologically inactive precursors - D3, also known as cholecalciferol, and D2, also known as ergocalciferol. The former, produced in the skin on exposure to UVB radiation (290 to 320 nm), is said to be more bioactive.
The human body manufactures vitamin D on exposure to sunshine, but the levels in some northern countries are so weak during the winter months that our body makes no vitamin D at all, meaning that dietary supplements and fortified foods are seen by many as the best way to boost intakes.