Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate.
Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate.
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DOI：
10.2903/j.efsa.2023.8145
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发表时间：
2023-08
期刊：
影响因子：
3.3
通讯作者：
Naska, Androniki
中科院分区：
文献类型：
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作者：
Turck, Dominique;Bohn, Torsten;Castenmiller, Jacqueline;de Henauw, Stefaan;Hirsch-Ernst, Karen-Ildico;Knutsen, Helle Katrine;Maciuk, Alexandre;Mangelsdorf, Inge;McArdle, Harry J.;Pentieva, Kristina;Siani, Alfonso;Thies, Frank;Tsabouri, Sophia;Vinceti, Marco;Lanham-New, Susan;Passeri, Giovanni;Craciun, Ionut;Fabiani, Lucia;De Sousa, Rita Ferreira;Martino, Laura;Martinez, Silvia Valtuena;Naska, Androniki
关键词：
根据欧盟委员会的两次请求，欧空局营养、新型食品和食物过敏原小组(NDA)被要求就修订维生素D的可容忍摄入量(UL)发表科学意见，并提出一水合钙到维生素D3的转换系数(Cf)，用于标签目的。维生素D指的是麦角钙化醇(维生素D2)、胆钙化醇(维生素D3)和一水合钙二醇。对文献进行了系统综述，以评估一水合钙与维生素D3对血清25(OH)D浓度的相对生物利用度，以及维生素D摄入量过多的主要不良健康影响，即持续性高钙血症/高钙尿症和与肌肉骨骼健康相关的终点(如跌倒、骨折、骨量/密度及其指数)。根据现有证据，小组建议一水合钙二醇的CF值为2.5，用于标签目的。持续性高钙尿症可能是维生素D过量的先兆，它可能是持续性高钙血症的早期征兆，被选为维生素D UL的关键终点，从两个随机对照试验中确定了每天250 μg的最低观察不良反应水平(LOAEL)，其中应用了2.5的不确定系数来说明没有观察到不良反应水平(NOAEL)。成人(包括孕妇和哺乳期妇女)和11-17 μ岁的青少年每天的维生素D当量UL为100 g，因为没有理由相信处于骨骼快速形成和生长阶段的青少年与成年人相比对维生素D的耐受性较低。对于1-10 岁的儿童，考虑到他们较小的身体尺寸，建立了50 μg VDE/天的UL。根据现有的摄入量数据，欧洲人口不太可能超过UL，除了经常使用含有高剂量维生素D的食品补充剂的人。
Following two requests from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for vitamin D and to propose a conversion factor (CF) for calcidiol monohydrate into vitamin D3 for labelling purposes. Vitamin D refers to ergocalciferol (vitamin D2), cholecalciferol (vitamin D3), and calcidiol monohydrate. Systematic reviews of the literature were conducted to assess the relative bioavailability of calcidiol monohydrate versus vitamin D3 on serum 25(OH)D concentrations, and for priority adverse health effects of excess vitamin D intake, namely persistent hypercalcaemia/hypercalciuria and endpoints related to musculoskeletal health (i.e. falls, bone fractures, bone mass/density and indices thereof). Based on the available evidence, the Panel proposes a CF for calcidiol monohydrates of 2.5 for labelling purposes. Persistent hypercalciuria, which may be an earlier sign of excess vitamin D than persistent hypercalcaemia, is selected as the critical endpoint on which to base the UL for vitamin D. A lowest‐observed‐adverse‐effect‐level (LOAEL) of 250 μg/day is identified from two randomised controlled trials in humans, to which an uncertainty factor of 2.5 is applied to account for the absence of a no‐observed‐adverse‐effect‐level (NOAEL). A UL of 100 μg vitamin D equivalents (VDE)/day is established for adults (including pregnant and lactating women) and for adolescents aged 11–17 years, as there is no reason to believe that adolescents in the phase of rapid bone formation and growth have a lower tolerance for vitamin D compared to adults. For children aged 1–10 years, a UL of 50 μg VDE/day is established by considering their smaller body size. Based on available intake data, European populations are unlikely to exceed the UL, except for regular users of food supplements containing high doses of vitamin D.
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DOI：
10.3390/geriatrics7010013
发表时间：
2022-01-07
期刊：
Geriatrics (Basel, Switzerland)
影响因子：
--
作者：
Okoye C;Calsolaro V;Niccolai F;Calabrese AM;Franchi R;Rogani S;Coppini G;Morelli V;Caraccio N;Monzani F
通讯作者：
Monzani F
影响因子：
3.3
作者：
Agostoni, Carlo;Canani, Roberto Berni;Verhagen, Hans
通讯作者：
Verhagen, Hans
影响因子：
3.5
作者：
Ahn J;Yu K;Stolzenberg-Solomon R;Simon KC;McCullough ML;Gallicchio L;Jacobs EJ;Ascherio A;Helzlsouer K;Jacobs KB;Li Q;Weinstein SJ;Purdue M;Virtamo J;Horst R;Wheeler W;Chanock S;Hunter DJ;Hayes RB;Kraft P;Albanes D
通讯作者：
Albanes D
影响因子：
3.3
作者：
Agostoni, Carlo;Bresson, Jean-Louis;Verhagen, Hans
通讯作者：
Verhagen, Hans
影响因子：
4.7
作者：
通讯作者：
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