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Clin Nutr. 2019 Apr 11. pii: S0261-5614(19)30161-X. doi: 10.1016/j.clnu.2019.04.006. [Epub ahead of print]

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

Author information

1
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. Electronic address: rcorcoy@santpau.cat.
2
Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
3
Institute of Metabolic Science, Addenbrookes Hospital, Cambridge, England, UK; Macarthur Clinical School, Western Sydney University, Sydney, Australia.
4
Department of Obstetrics and Gynecology, Medizinische Universitaet Graz, Graz, Austria.
5
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
6
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.
7
KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Belgium; Gynaecology and Obstetrics, University Hospitals Leuven, Belgium.
8
Universita Degli Studi di Padova, Padua, Italy.
9
Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
10
Department of Medicine III, Division of Endocrinology, Gender Medicine Unit, Medical University of Vienna, Vienna, Austria.
11
Division of Reproduction, Medical Faculty I, Poznan University of Medical Sciences, Poland.
12
National University of Ireland, Galway, Ireland.
13
Center for Pregnant Women with Diabetes, Department of Endocrinology and Obstetrics, Rigshospitalet, Copenhagen, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
14
Department of Gynaecology and Obstetrics, Odense University Hospital, Denmark; Department of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark; Steno Diabetes Center Odense, Odense University, Denmark.
15
Department of Gynaecology and Obstetrics, Odense University Hospital, Denmark; Department of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.
16
Recherche en Santé Lawson SA, St. Gallen, Switzerland.
17
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.
18
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Medical Psychology, Amsterdam, Netherlands.
19
Medical University of Graz, Core Facility Mass Spectrometry, Stiftingtalstrasse 24, 8010 Graz, Austria; Omics Center Graz, Stiftingtalstrasse 24, 8010 Graz, Austria.
20
Department of Internal Medicine, Endocrine Section, VU University Medical Center, Amsterdam, Netherlands.
21
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, Netherlands; Institute of Sport Science, University of Graz, Graz, Austria.

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

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

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