The calcifediol ingredient, developed and manufactured by DSM, is trademarked ampli-D.
DSM has also been successfully registered the new ingredient with Australia’s regulator Therapeutic Goods Administration (TGA).
At the moment, commercially available products contain cholecalciferol – another form of vitamin D3.
Calcifediol was found to be 3.2-fold more potent than cholecalciferol, thus is faster in rising vitamin D levels, according to a review of nine RCTS.
“When using dosages ≤ 25 μg/day, serum 25(OH) vitamin D increased by 1.5 ± 0.9 nmol/l for each 1 μg cholecalciferol, whereas this was 4.8 ± 1.2 nmol/l for oral calcifediol,” the researchers said.
Bioclinic Naturals is the first supplement brand to launch a finished product containing ampli-D. Bioclinic Naturals is a brand under Factors Group Australia.
Named Opti Active D, the supplement is already registered with the TGA and will be made available to healthcare practitioners from next month.
The supplement comes in the form of a tablet and each tablet contains 10 micrograms of ampli-D.
According to the public Australian Register of Therapeutic Goods (ARTG) summary, the product is permitted to make health claims such as “maintain/support healthy teeth”, “maintain/support bone health in post-menopausal women”, “maintain/support immune system health.”
The company decided to partner with DSM in launching a calcifediol supplement to bridge the current market gap, Evan Hayes, MD of Factors Group Australia told NutraIngredients-Asia.
“Currently, there is no vitamin D products that are considered very good for the practitioners; most commercial products are generic products.
“Practitioners are looking for high dose vitamin D supplements which are fast-acting for the at-risk populations,” Hayes said.
He pointed out that the at-risk populations included elderly suffering from osteoporosis, individuals with severe immunity problems, as well as those with insufficient amounts of vitamin D.
“Vitamin D insufficiency is linked to chronic problems such as osteoporosis, weakened immunity, and gut microbiome issues. We have been looking for a long time for a solution.”
Consumer demands
A recent global survey conducted by DSM found that 65 percent of the consumers are worried about their immune health and 62 percent associate vitamin D with boosting the immunity.
The DSM Consumer Immunity Panel examined the attitudes of 12,000 people towards immune health and was published last September.
Vitamin D has been receiving a high amount of attention from both the scientific community and public health authorities for its role in strengthening the immune system and even reducing COVID-19 infections and deaths.
“Through our products with purpose strategy, we are identifying real global health concerns and are working to develop industry-leading nutritional solutions, to support specific health areas, including immunity,” Mark van Nieuwland, program director for the innovation at DSM said.
The key challenge in developing the ingredient lies in ensuring the consistency of the product.
“[The production process] starts very similarly to the production of vitamin D and then through different process, we are able to make the more active form [calcifediol].
“Because it [calcifediol] is so highly active, the key challenge lies in how do we distribute it properly, how do we make sure that every gram of the product has exactly the same amount of active ingredient in there," van Nieuwland said.
To overcome the challenge, he said a large part was to work on the quality control and understanding the processing parameters from different angles.
The product R&D was conducted in Switzerland and the raw ingredient made in the US.
DSM is registering the ampli-D as a new dietary ingredient in a number of regions, including Japan, Europe, and Brazil.
Upcoming plans
There are plans to develop ampli-D into a supplement in multiple formats, as well as formulating a supplement that contains both ampli-D and other bioactive ingredients.
The dosage formats could include chewables, melts, and gummies suitable for children, said Hayes.
Since vitamin D can work synergistically with other ingredients such as calcium, magnesium, and zinc, there are also plans to consider combining ampli-D with these ingredients.
