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


Journal

Clinical nutrition (Edinburgh, Scotland)
ISSN: 1532-1983
Titre abrégé: Clin Nutr
Pays: England
ID NLM: 8309603

Informations de publication

Date de publication:
03 2020
Historique:
received: 10 12 2018
revised: 01 04 2019
accepted: 01 04 2019
pubmed: 6 5 2019
medline: 20 8 2021
entrez: 5 5 2019
Statut: ppublish

Résumé

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. The DALI vitamin D multicenter study enrolled women with prepregnancy body mass index (BMI) ≥ 29 kg/m 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. 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. ISRCTN70595832.

Sections du résumé

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
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.

Identifiants

pubmed: 31053513
pii: S0261-5614(19)30161-X
doi: 10.1016/j.clnu.2019.04.006
pii:
doi:

Substances chimiques

Blood Glucose 0
Insulin 0
Vitamins 0
Vitamin D 1406-16-2

Banques de données

ISRCTN
['ISRCTN70595832']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

976-984

Informations de copyright

Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Auteurs

Rosa Corcoy (R)

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.

Lilian C Mendoza (LC)

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

David Simmons (D)

Institute of Metabolic Science, Addenbrookes Hospital, Cambridge, England, UK; Macarthur Clinical School, Western Sydney University, Sydney, Australia.

Gernot Desoye (G)

Department of Obstetrics and Gynecology, Medizinische Universitaet Graz, Graz, Austria.

J M Adelantado (JM)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

Ana Chico (A)

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.

Roland Devlieger (R)

KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Belgium; Gynaecology and Obstetrics, University Hospitals Leuven, Belgium.

Andre van Assche (A)

KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Belgium; Gynaecology and Obstetrics, University Hospitals Leuven, Belgium.

Sander Galjaard (S)

KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Belgium; Gynaecology and Obstetrics, University Hospitals Leuven, Belgium.

Dirk Timmerman (D)

KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Belgium; Gynaecology and Obstetrics, University Hospitals Leuven, Belgium.

Annunziata Lapolla (A)

Universita Degli Studi di Padova, Padua, Italy.

Maria G Dalfra (MG)

Universita Degli Studi di Padova, Padua, Italy.

Alessandra Bertolotto (A)

Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

Jürgen Harreiter (J)

Department of Medicine III, Division of Endocrinology, Gender Medicine Unit, Medical University of Vienna, Vienna, Austria.

Ewa Wender-Ozegowska (E)

Division of Reproduction, Medical Faculty I, Poznan University of Medical Sciences, Poland.

Agnieszka Zawiejska (A)

Division of Reproduction, Medical Faculty I, Poznan University of Medical Sciences, Poland.

Alexandra Kautzky-Willer (A)

Department of Medicine III, Division of Endocrinology, Gender Medicine Unit, Medical University of Vienna, Vienna, Austria.

Fidelma P Dunne (FP)

National University of Ireland, Galway, Ireland.

Peter Damm (P)

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.

Elisabeth R Mathiesen (ER)

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.

Dorte M Jensen (DM)

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.

Lise Lotte T Andersen (LLT)

Department of Gynaecology and Obstetrics, Odense University Hospital, Denmark; Department of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.

Mette Tanvig (M)

Department of Gynaecology and Obstetrics, Odense University Hospital, Denmark; Department of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.

David J Hill (DJ)

Recherche en Santé Lawson SA, St. Gallen, Switzerland.

Judith G Jelsma (JG)

Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, Netherlands.

Frank J Snoek (FJ)

Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Medical Psychology, Amsterdam, Netherlands.

Harald Köfeler (H)

Medical University of Graz, Core Facility Mass Spectrometry, Stiftingtalstrasse 24, 8010 Graz, Austria; Omics Center Graz, Stiftingtalstrasse 24, 8010 Graz, Austria.

Martin Trötzmüller (M)

Medical University of Graz, Core Facility Mass Spectrometry, Stiftingtalstrasse 24, 8010 Graz, Austria; Omics Center Graz, Stiftingtalstrasse 24, 8010 Graz, Austria.

Paul Lips (P)

Department of Internal Medicine, Endocrine Section, VU University Medical Center, Amsterdam, Netherlands.

Mireille N M van Poppel (MNM)

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.

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