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DALI 维生素 D 随机对照试验预防妊娠糖尿病:除了维生素 D 充足之外,没有显示出主要益处。

The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention: No major benefit shown besides vitamin D sufficiency.

机构信息

Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain; Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; CIBER Bioengineering, Biomaterials and Nanotechnology, Instituto de Salud Carlos III, Madrid, Spain.

Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.

出版信息

Clin Nutr. 2020 Mar;39(3):976-984. doi: 10.1016/j.clnu.2019.04.006. Epub 2019 Apr 11.

DOI:10.1016/j.clnu.2019.04.006
PMID:31053513
Abstract

BACKGROUND & AIMS: As vitamin D deficiency is associated with an increased risk of gestational diabetes mellitus (GDM), we aimed to test vitamin D supplementation as a strategy to reduce GDM risk (evaluated after fasting plasma glucose (FPG), insulin resistance and weight gain) in pregnant overweight/obese women.

METHODS

The DALI vitamin D multicenter study enrolled women with prepregnancy body mass index (BMI) ≥ 29 kg/m, ≤19 + 6 weeks of gestation and without GDM. Participants were randomized to receive 1600 IU/day vitamin D3 or placebo (each with or without lifestyle intervention) on top of (multi)vitamins supplements. Women were assessed for vitamin D status (sufficiency defined as serum 25-hydroxyvitamin D (25(OH)D) ≥ 50 nmol/l), FPG, insulin resistance and weight at baseline, 24-28 and 35-37 weeks. Linear or logistic regression analyses were performed to assess intervention effects.

RESULTS

Average baseline serum 25(OH)D was ≥50 nmol/l across all study sites. In the vitamin D intervention arm (n = 79), 97% of participants achieved target serum vitamin 25(OH)D (≥50 nmol/l) at 24-28 weeks and 98% at 35-37 weeks vs 74% and 78% respectively in the placebo arm (n = 75, p < 0.001). A small but significantly lower FPG (-0.14 mmol/l; CI95 -0.28, -0.00) was observed at 35-37 weeks with the vitamin D intervention without any additional difference in metabolic status, perinatal outcomes or adverse event rates.

CONCLUSION

In the DALI vitamin D trial, supplementation with 1600 IU vitamin D3/day achieved vitamin D sufficiency in virtually all pregnant women and a small effect in FPG at 35-37 weeks. The potential of vitamin D supplementation for GDM prevention in vitamin D sufficient populations appears to be limited.

TRIAL REGISTRATION NUMBER

ISRCTN70595832.

摘要

背景与目的

由于维生素 D 缺乏与妊娠糖尿病(GDM)风险增加有关,我们旨在测试维生素 D 补充作为一种策略,以降低超重/肥胖孕妇的 GDM 风险(在空腹血糖(FPG)、胰岛素抵抗和体重增加后评估)。

方法

DALI 维生素 D 多中心研究纳入了孕前体重指数(BMI)≥29kg/m²、妊娠≤19+6 周且无 GDM 的女性。参与者被随机分配接受 1600IU/天维生素 D3 或安慰剂(均加或不加生活方式干预),同时服用多种维生素补充剂。在基线、24-28 周和 35-37 周时,评估女性的维生素 D 状态(定义为血清 25-羟维生素 D(25(OH)D)≥50nmol/L)、FPG、胰岛素抵抗和体重。采用线性或逻辑回归分析评估干预效果。

结果

所有研究地点的平均基线血清 25(OH)D 均≥50nmol/L。在维生素 D 干预组(n=79)中,97%的参与者在 24-28 周时达到目标血清维生素 25(OH)D(≥50nmol/L),而在安慰剂组(n=75)中分别为 74%和 78%(p<0.001)。在 35-37 周时,维生素 D 干预组的 FPG 略有降低(-0.14mmol/L;95%CI95-0.28,-0.00),但代谢状态、围产儿结局或不良事件发生率无差异。

结论

在 DALI 维生素 D 试验中,每天补充 1600IU 维生素 D3 可使几乎所有孕妇达到维生素 D 充足,并在 35-37 周时使 FPG 略有降低。维生素 D 补充预防维生素 D 充足人群 GDM 的潜力似乎有限。

试验注册号

ISRCTN70595832。

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