背景:大量研究表明血清25-羟基维生素D(25[OH]D)浓度与多种常见疾病之间存在关联,包括骨骼肌肉,新陈代谢,心血管,恶性,自身免疫,和传染病。尽管血清25(OH)D浓度与许多疾病之间的因果关系尚未明确确定,这些关联导致一般人群广泛补充维生素D,并增加了25(OH)D的实验室检测.这种增加维生素D使用的获益-风险比尚不清楚,最佳维生素D摄入量和25(OH)D检测对疾病预防的作用仍不确定。
目的:制定使用维生素D(胆钙化醇[维生素D3]或麦角钙化醇[维生素D2])的临床指南,以降低无维生素D治疗或25(OH)D检测指征的个体的疾病风险。
方法:多学科临床专家小组,以及指导方法论和系统文献综述的专家,确定并优先考虑与使用维生素D和25(OH)D检测降低疾病风险相关的14个临床相关问题。该小组优先考虑一般人群的随机安慰剂对照试验(没有确定的维生素D治疗或25[OH]D测试的适应症),评估经验性维生素D在整个生命周期中的作用,以及在选择条件(怀孕和糖尿病前期)。小组将“经验性补充”定义为维生素D摄入量,即(a)超过饮食参考摄入量(DRI)和(b)在没有测试25(OH)D的情况下实施。系统评价向电子数据库查询与这14个临床问题相关的出版物。建议的分级,评估,发展,和评估(GRADE)方法用于评估证据和指导建议的确定性。该方法结合了患者代表的观点和考虑的患者价值,所需的成本和资源,可接受性和可行性,以及拟议建议对健康公平的影响。制定该临床指南的过程没有使用风险评估框架,也没有旨在取代目前的维生素D的DRI。
结果:专家组建议对1至18岁的儿童和青少年补充经验性维生素D,以预防营养病,因为它有可能降低呼吸道感染的风险;对于75岁及以上的人,因为它有可能降低死亡风险;子宫内死亡率,早产,小于胎龄儿的出生,和新生儿死亡率;以及那些高危糖尿病前期患者,因为它有可能减少糖尿病的进展。因为纳入临床试验的维生素D剂量差异很大,许多试验参与者被允许继续他们自己的含维生素D的补充剂,对于所考虑的人群,经验性维生素D补充的最佳剂量仍不清楚.对于50岁以上的非孕妇,需要维生素D。小组建议通过每日服用维生素D来补充,而不是间歇性使用高剂量。该小组建议不要在目前的DRI之上补充经验性维生素D,以降低75岁以下健康成年人的疾病风险。没有临床试验证据支持在普通人群中常规筛查25(OH)D。肥胖或肤色较黑的人也不例外,并且没有明确的证据确定所考虑人群中疾病预防所需的25(OH)D的最佳目标水平;因此,小组建议在所有考虑的人群中进行常规25(OH)D测试。小组判断,在大多数情况下,经验性维生素D补充剂价格低廉,可行,健康的个人和医疗保健专业人员都可以接受,对健康公平没有负面影响。
结论:专家组建议1至18岁的人和75岁以上的成年人使用经验性维生素D,那些怀孕的人,和那些高危前驱糖尿病患者。由于缺乏富含维生素D的天然食物来源,经验性补充可以通过强化食品和含有维生素D的补充剂的组合来实现。基于缺乏支持性临床试验证据,小组建议在没有明确适应症的情况下进行常规25(OH)D测试。这些建议并不是要取代目前维生素D的DRIs,它们也不适用于有维生素D治疗或25(OH)D检测适应症的人.需要进一步的研究来确定特定健康益处的最佳25(OH)D水平。
BACKGROUND: Numerous studies demonstrate associations between serum concentrations of 25-hydroxyvitamin D (25[OH]D) and a variety of common disorders, including musculoskeletal, metabolic, cardiovascular, malignant, autoimmune, and infectious diseases. Although a causal link between serum 25(OH)D concentrations and many disorders has not been clearly established, these associations have led to widespread supplementation with vitamin D and increased laboratory testing for 25(OH)D in the general population. The benefit-risk ratio of this increase in vitamin D use is not clear, and the optimal vitamin D intake and the role of testing for 25(OH)D for disease prevention remain uncertain.
OBJECTIVE: To develop clinical
guidelines for the use of vitamin D (cholecalciferol [vitamin D3] or ergocalciferol [vitamin D2]) to lower the risk of disease in individuals without established indications for vitamin D treatment or 25(OH)D testing.
METHODS: A multidisciplinary panel of clinical experts, along with experts in
guideline methodology and systematic literature review, identified and prioritized 14 clinically relevant questions related to the use of vitamin D and 25(OH)D testing to lower the risk of disease. The panel prioritized randomized placebo-controlled trials in general populations (without an established indication for vitamin D treatment or 25[OH]D testing), evaluating the effects of empiric vitamin D administration throughout the lifespan, as well as in select conditions (pregnancy and prediabetes). The panel defined \"empiric supplementation\" as vitamin D intake that (a) exceeds the Dietary Reference Intakes (DRI) and (b) is implemented without testing for 25(OH)D. Systematic reviews queried electronic databases for publications related to these 14 clinical questions. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and guide recommendations. The approach incorporated perspectives from a patient representative and considered patient values, costs and resources required, acceptability and feasibility, and impact on health equity of the proposed recommendations. The process to develop this clinical
guideline did not use a risk assessment framework and was not designed to replace current DRI for vitamin D.
RESULTS: The panel suggests empiric vitamin D supplementation for children and adolescents aged 1 to 18 years to prevent nutritional rickets and because of its potential to lower the risk of respiratory tract infections; for those aged 75 years and older because of its potential to lower the risk of mortality; for those who are pregnant because of its potential to lower the risk of preeclampsia, intra-uterine
mortality, preterm birth, small-for-gestational-age birth, and neonatal
mortality; and for those with high-risk prediabetes because of its potential to reduce progression to diabetes. Because the vitamin D doses in the included clinical trials varied considerably and many trial participants were allowed to continue their own vitamin D-containing supplements, the optimal doses for empiric vitamin D supplementation remain unclear for the populations considered. For nonpregnant people older than 50 years for whom vitamin D is indicated, the panel suggests supplementation via daily administration of vitamin D, rather than intermittent use of high doses. The panel suggests against empiric vitamin D supplementation above the current DRI to lower the risk of disease in healthy adults younger than 75 years. No clinical trial evidence was found to support routine screening for 25(OH)D in the general population, nor in those with obesity or dark complexion, and there was no clear evidence defining the optimal target level of 25(OH)D required for disease prevention in the populations considered; thus, the panel suggests against routine 25(OH)D testing in all populations considered. The panel judged that, in most situations, empiric vitamin D supplementation is inexpensive, feasible, acceptable to both healthy individuals and health care professionals, and has no negative effect on health equity.
CONCLUSIONS: The panel suggests empiric vitamin D for those aged 1 to 18 years and adults over 75 years of age, those who are pregnant, and those with high-risk prediabetes. Due to the scarcity of natural food sources rich in vitamin D, empiric supplementation can be achieved through a combination of fortified foods and supplements that contain vitamin D. Based on the absence of supportive clinical trial evidence, the panel suggests against routine 25(OH)D testing in the absence of established indications. These recommendations are not meant to replace the current DRIs for vitamin D, nor do they apply to people with established indications for vitamin D treatment or 25(OH)D testing. Further research is needed to determine optimal 25(OH)D levels for specific health benefits.