Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon.
Scholars in HeAlth Research Program (SHARP), American University of Beirut, Beirut, Lebanon.
Cochrane Database Syst Rev. 2024 Oct 1;10(10):CD011800. doi: 10.1002/14651858.CD011800.pub2.
Vitamin D deficiency following bariatric surgery is common and is expected to be associated with a deleterious impact on the skeleton. However, the benefits of vitamin D supplementation and the optimal dose in this population is currently unknown. The available guidelines on the topic are derived from experts' opinions, and are not evidence based.
To compare the effects of different doses of vitamin D supplementation (low dose (less than 600 international units (IU)/day), moderate dose (600 IU/day to 3500 IU/day), high dose (greater than 3500 IU/day)) to each other or to placebo in adults living with obesity undergoing bariatric surgery.
We searched CENTRAL, MEDLINE, Embase, LILACS, two trial registries, and the reference lists of systematic reviews, articles, and health technology assessment reports without language restrictions. The last search of all databases was 27 June 2023, except Embase, which we searched on 14 August 2015.
We included randomised controlled trials or controlled clinical trials on vitamin D supplementation comparing different doses or comparing vitamin D to placebo in people undergoing bariatric surgery.
We used standard Cochrane methods. Primary outcomes were fractures and adverse events. Secondary outcomes were vitamin D status, all-cause mortality, bone mineral change, secondary hyperparathyroidism, health-related quality of life, and muscle strength. We used GRADE to assess the certainty of the evidence for each outcome in each comparison.
We identified five trials with 314 participants. We included three trials in the quantitative analysis. Moderate-dose vitamin D compared to placebo One trial compared moderate-dose vitamin D (3200 IU/day) to placebo. Moderate-dose vitamin D, compared to placebo, may improve vitamin D status and may result in little to no difference in the achieved parathyroid hormone level (achieved 25-hydroxyvitamin D level: mean difference (MD) 13.60 ng/mL, 95% confidence interval (CI) 7.94 to 19.26; achieved parathyroid hormone level: -6.60 pg/mL, 95% CI -17.12 to 3.92; 1 study, 79 participants; low-certainty evidence). The trial reported no adverse events in the moderate-dose vitamin D arm, but did not provide any information on adverse events in the placebo arm. There were no data on fractures, all-cause mortality, bone density change, health-related quality of life, and muscle strength. High-dose vitamin D compared to moderate-dose vitamin D Two trials in Roux-en-Y gastric bypass compared moderate-dose (equivalent dose 800 IU/day to 2000 IU/day) to high-dose (equivalent dose 5000 IU/day to 7943 IU/day) vitamin D. The evidence of high-dose vitamin D on adverse events is very uncertain (risk ratio (RR) 5.18, 95% CI 0.23 to 116.56; 2 studies, 81 participants; very low-certainty evidence). High-dose vitamin D may increase 25-hydroxyvitamin D levels compared to a moderate dose at 12 months, but the evidence is very uncertain (MD 15.55 ng/mL, 95% CI 3.50 to 27.61; I = 62%; 2 studies, 73 participants; very low-certainty evidence). High-dose vitamin D may have little to no effect on parathyroid hormone levels compared to a moderate dose at 12 months, but the evidence is very uncertain (MD 2.15 pg/mL, 95% CI -21.31 to 17.01; I = 0%; 2 studies, 72 participants; very low-certainty evidence). High-dose vitamin D may have little to no effect on mortality and bone mineral density at the lumbar spine, hip, and forearm, but the evidence is very uncertain. There were no data on fractures, health-related quality of life, or muscle strength.
AUTHORS' CONCLUSIONS: No trials reported on fractures and the evidence available on adverse events is scarce. Moderate-dose vitamin D may improve vitamin D status and may result in little to no improvement in parathyroid hormone levels compared with placebo. High-dose vitamin D supplementation (greater than 3500 IU/day) may increase 25-hydroxyvitamin D levels, and may have little to no effect on parathyroid hormone levels, compared to a moderate dose, but the evidence for both is very uncertain. The currently available limited evidence may not have a significant impact on practice. Further studies are needed to explore the impact of vitamin D supplementation on fractures, adverse events, and musculoskeletal parameters in people undergoing bariatric surgery.
减重手术后维生素 D 缺乏很常见,预计会对骨骼产生有害影响。然而,目前对于该人群补充维生素 D 的最佳剂量及其益处尚不清楚。关于这个主题的现有指南是基于专家意见,而不是基于证据。
比较不同剂量的维生素 D 补充剂(低剂量(少于 600 国际单位(IU)/天)、中剂量(600 IU/天至 3500 IU/天)、高剂量(大于 3500 IU/天))之间以及与安慰剂在接受减重手术的肥胖成年人中的效果。
我们检索了 CENTRAL、MEDLINE、Embase、LILACS、两个试验注册库以及系统评价、文章和卫生技术评估报告的参考文献,没有语言限制。所有数据库的最后一次检索是 2023 年 6 月 27 日,除了 Embase,我们于 2015 年 8 月 14 日检索了该数据库。
我们纳入了比较不同剂量或比较维生素 D 与安慰剂的随机对照试验或对照临床试验,研究对象为正在接受减重手术的人群。
我们使用了标准的 Cochrane 方法。主要结局为骨折和不良事件。次要结局为维生素 D 状况、全因死亡率、骨密度变化、继发性甲状旁腺功能亢进、健康相关生活质量和肌肉力量。我们使用 GRADE 评估每个比较的每个结局的证据确定性。
我们确定了五项试验,共 314 名参与者。我们对三项试验进行了定量分析。
中剂量维生素 D 与安慰剂相比一项试验比较了中剂量维生素 D(3200 IU/天)与安慰剂。与安慰剂相比,中剂量维生素 D 可能会改善维生素 D 状态,并且可能对甲状旁腺激素水平的改善作用不大(达到 25-羟维生素 D 水平:平均差值(MD)13.60ng/mL,95%置信区间(CI)7.94 至 19.26;达到甲状旁腺激素水平:-6.60pg/mL,95%CI-17.12 至 3.92;1 项研究,79 名参与者;低确定性证据)。试验报告中在中剂量维生素 D 组没有不良事件,但没有提供安慰剂组的不良事件信息。没有骨折、全因死亡率、骨密度变化、健康相关生活质量和肌肉力量的数据。
高剂量维生素 D 与中剂量维生素 D 相比两项在 Roux-en-Y 胃旁路手术中进行的试验比较了中剂量(相当于 800 IU/天至 2000 IU/天)与高剂量(相当于 5000 IU/天至 7943 IU/天)维生素 D。关于高剂量维生素 D 对不良事件的证据非常不确定(风险比(RR)5.18,95%CI 0.23 至 116.56;2 项研究,81 名参与者;非常低确定性证据)。高剂量维生素 D 可能会比中剂量在 12 个月时增加 25-羟维生素 D 水平,但证据非常不确定(MD 15.55ng/mL,95%CI 3.50 至 27.61;I = 62%;2 项研究,73 名参与者;非常低确定性证据)。高剂量维生素 D 对甲状旁腺激素水平的影响可能与中剂量相似或稍低,但证据非常不确定(MD 2.15pg/mL,95%CI-21.31 至 17.01;I = 0%;2 项研究,72 名参与者;非常低确定性证据)。高剂量维生素 D 对腰椎、髋部和前臂的骨矿物质密度、死亡率可能影响不大,但证据非常不确定。没有骨折、健康相关生活质量或肌肉力量的数据。
没有试验报告骨折情况,关于不良事件的证据很少。中剂量维生素 D 可能会改善维生素 D 状态,并且与安慰剂相比,甲状旁腺激素水平可能改善不大。与中剂量相比,高剂量维生素 D 补充剂(大于 3500 IU/天)可能会增加 25-羟维生素 D 水平,并且可能对甲状旁腺激素水平的影响不大,但这两种情况的证据都非常不确定。目前有限的证据可能对实践没有重大影响。需要进一步的研究来探讨维生素 D 补充剂对减重手术后骨折、不良事件和肌肉骨骼参数的影响。