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

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

Rosa Corcoy  1 , Lilian C Mendoza  2 , David Simmons  3 , Gernot Desoye  4 , J M Adelantado  5 , Ana Chico  6 , Roland Devlieger  7 , Andre van Assche  7 , Sander Galjaard  7 , Dirk Timmerman  7 , Annunziata Lapolla  8 , Maria G Dalfra  8 , Alessandra Bertolotto  9 , Jürgen Harreiter  10 , Ewa Wender-Ozegowska  11 , Agnieszka Zawiejska  11 , Alexandra Kautzky-Willer  10 , Fidelma P Dunne  12 , Peter Damm  13 , Elisabeth R Mathiesen  13 , Dorte M Jensen  14 , Lise Lotte T Andersen  15 , Mette Tanvig  15 , David J Hill  16 , Judith G Jelsma  17 , Frank J Snoek  18 , Harald Köfeler  19 , Martin Trötzmüller  19 , Paul Lips  20 , Mireille N M van Poppel  21
Affiliations
Randomized Controlled Trial

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

Rosa Corcoy et al. Clin Nutr. 2020 Mar.

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/m2, ≤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.

Keywords: Fasting plasma glucose; Fasting plasma insulin; Gestational diabetes mellitus; Pregnancy; Vitamin D sufficiency; Vitamin D supplementation.

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