Scientific Documents

Calcium + Vitamin D3 chewing tablets and bone loss - Scientific substantiation of a health claim related to Calcium plus Vitamin D3 chewing tablets and reduction of the risk of osteoporotic fractures by reducing bone loss pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Summary (78 KB)

Opinion (151 KB)

Summary

Following an application from Abtei Pharma Vertriebs GmbH submitted pursuant to Article 14, of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Calcium + Vitamin D3 chewing tablets and reduction of the risk of bone loss and osteoporotic fractures.

The scope of the application was proposed to fall under a health claim referring to disease risk reduction.

The food constituent that is the subject of the claim is chewing tablets containing calcium or calcium and vitamin D as active ingredients. Both calcium and vitamin D are well recognised nutrients and are measurable in foods by established methods. Calcium occurs naturally in foods in many forms which are generally well utilised by the body. This opinion will apply to all forms of calcium and vitamin D naturally occurring in foods and those forms authorised for addition to foods and for use in food supplements from all sources with appropriate bioavailability. The Panel considers that the food constituents calcium and vitamin D are sufficiently characterised.

The claimed effect is “improves bone density” and “reduces the risk of osteoporotic fracture”. The target group is women 50 years and older. The Panel considers that limiting the reduction of BMD in postmenopausal women might be beneficial to human health by reducing the risk of osteoporotic fractures.

A total of 53 publications were considered by the applicant as pertinent to the claim, 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. Excluded were trials that studied calcium/vitamin D naturally present in the diet.

The Panel considers that, taken together, the meta-analyses consistently support a cause and effect relationship between the supplementation with calcium alone, or the combined supplementation with calcium and vitamin D, and reduction in the loss of BMD and reduction of the risk of vertebral and non-vertebral osteoporotic fractures in post-menopausal women. The Panel further considers that reducing the loss of BMD in postmenopausal women by supplementation with calcium alone or combined supplementation with calcium and vitamin D may contribute to a reduction in the risk of bone fractures.

In the meta-analyses of the studies on the effect of calcium, alone supplementation with calcium was in the range of 500-1600 mg/d in addition to diet, while in the meta-analyses of the studies on the effect of calcium and vitamin D, combined supplementation with calcium and vitamin D was in the range of 200-1200 mg/d and 200 - 800 IU/d, respectively, in addition to diet. 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 osteoporotic fractures.
The Panel concludes that, on the basis of the data provided, a cause and effect relationship has been established between the intake of calcium, either alone or in combination with vitamin D, and reducing the loss of BMD in postmenopausal women. Reducing the loss of BMD may contribute to a reduction in the risk of bone fractures.

The following wordings reflect the scientific evidence: “Calcium 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” and “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 Panel considers that the information provided is insufficient to establish conditions of use for the claims.