Clinical nutrition (Edinburgh, Scotland). 2019 Apr 11. pii: S0261-5614(19)30161-X. doi: 10.1016/j.clnu.2019.04.006 |
The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention: No major benefit shown besides vitamin D sufficiency. |
Corcoy R1, Mendoza LC2, Simmons D3, Desoye G4, Adelantado JM5, Chico A6, Devlieger R7, van Assche A8, Galjaard S9, Timmerman D10, Lapolla A11, Dalfra MG12, Bertolotto A13, Harreiter J14, Wender-Ozegowska E15, Zawiejska A16, Kautzky-Willer A17, Dunne FP18, Damm P19, Mathiesen ER20, Jensen DM21, Andersen LLT22, Tanvig M23, Hill DJ24, Jelsma JG25, Snoek FJ26, Köfeler H27, Trötzmüller M28, Lips P29, van Poppel MNM30 |
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. |
Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. |
KEYWORDS: Fasting plasma glucose, Fasting plasma insulin, Gestational diabetes mellitus, Pregnancy, Vitamin D sufficiency, Vitamin D supplementation |
Publikations ID: 31053513 Quelle: öffnen |