GSK company appeals vitamin D/calcium dosage restrictions

By Shane Starling

- Last updated on GMT

Related tags Osteoporosis Vitamin d

GlaxoSmithKline-owned German firm, Abtei Pharma Vertriebs, wants the European Food Safety Authority (EFSA) to reconsider its summer 2009 opinion that dose levels could not be established for a calcium/vitamin D bone health claim.

The company submitted comments to the European Commission highlighting evidence indicating why its proposed dosages of 1000mg of calcium and 800IU vitamin D3, should be approved and usable on its fortified chewing tablets aimed at post-menopausal women.

“…post-menopausal women need to be provided with the appropriate supplement levels to reduce risk of osteoporotic bone fractures effectively,”​ the company wrote.

“This reflects also the recent views, as expressed by health organisations like the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).”

These groups have recommend minimum daily amounts of 1000 mg calcium and 800 IU for vitamin D per day,​Abtei Pharma Vertriebs noted.

Mixed bag

Abtei Pharma Vertriebs gained a mixed article 14 disease reduction opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA). That opinion can be found here​.

It agreed calcium and/or calcium plus vitamin D supplementation could reduce the loss of bone mineral density (BMD) and with that the risk of bone fractures in post-menopausal women.

The NDA said the evidence submitted, including meta-analyses, did not provide evidence to back the proposed dosages.

The Panel notes that in the evidence provided there is limited information about the dose-response relationship of calcium and vitamin D and BMD or osteoporoticfractures."

The NDA recommended the wording: “Calcium and vitamin D may reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor in the development of osteoporotic bone fractures.”

The wording is usable for any calcium or vitamin D product with a similar composition.

Dossier defects

EFSA reviewed 53 publications cited by Abtei, including 43 randomized controlled trials (RCT) in humans and 10 meta-analyses of RCTs in which calcium, vitamin D or calcium in combination with vitamin D were used to prevent bone fracture and osteoporotic bone loss.

In its letter Abtei Pharma Vertriebs said the dosage in some trials referenced in its dossier had been misreported in a meta-analyses and were in fact between 500mg-1200mg for calcium, not 200mg-1200mg, as reported. Similarly, vitamin D should have read 500IU-800IU, not 200IU-800IU.

It also isolated other trials that indicated why high-dose supplementation benefitted bone health and why they should be reconsidered by the NDA.

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