TY - JOUR
T1 - The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention: No major benefit shown besides vitamin D sufficiency
AU - Corcoy, Rosa
AU - Mendoza, Lilian C.
AU - Simmons, David
AU - Desoye, Gernot
AU - Adelantado, J. M.
AU - Chico, Ana
AU - Devlieger, Roland
AU - van Assche, Andre
AU - Galjaard, Sander
AU - Timmerman, Dirk
AU - Lapolla, Annunziata
AU - Dalfra, Maria G.
AU - Bertolotto, Alessandra
AU - Harreiter, J. rgen
AU - Wender-Ozegowska, Ewa
AU - Zawiejska, Agnieszka
AU - Kautzky-Willer, Alexandra
AU - Dunne, Fidelma P.
AU - Damm, Peter
AU - Mathiesen, Elisabeth R.
AU - Jensen, Dorte M.
AU - Andersen, Lise Lotte T.
AU - Tanvig, Mette
AU - Hill, David J.
AU - Jelsma, Judith G.
AU - Snoek, Frank J.
AU - Köfeler, Harald
AU - Trötzmüller, Martin
AU - Lips, Paul
AU - van Poppel, Mireille N. M.
N1 - Funding Information: This project received funding from the European Community's 7th Framework Program (FP7/2007–2013; grant agreement no. 242187 ). In the Netherlands, additional funding was provided by the Netherlands Organization for Health Research and Development (ZonMW) (Grant nr 200310013 ). In the UK, the DALI team acknowledges the support received from the NIHR Clinical Research Network: Eastern, especially the local diabetes clinical and research teams based in Cambridge. In Spain, additional funding was provided by CAIBER 1527-B-226 . The funders had no role in any aspect of the study beyond 501 funding. Funding Information: This project received funding from the European Community's 7th Framework Program (FP7/2007?2013; grant agreement no. 242187). In the Netherlands, additional funding was provided by the Netherlands Organization for Health Research and Development (ZonMW) (Grant nr 200310013). In the UK, the DALI team acknowledges the support received from the NIHR Clinical Research Network: Eastern, especially the local diabetes clinical and research teams based in Cambridge. In Spain, additional funding was provided by CAIBER 1527-B-226. The funders had no role in any aspect of the study beyond 501 funding. Publisher Copyright: © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - 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 2 , ≤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
AB - 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 2 , ≤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
KW - Fasting plasma glucose
KW - Fasting plasma insulin
KW - Gestational diabetes mellitus
KW - Pregnancy
KW - Vitamin D sufficiency
KW - Vitamin D supplementation
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85064956408&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31053513
UR - http://www.scopus.com/inward/record.url?scp=85064956408&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.clnu.2019.04.006
DO - https://doi.org/10.1016/j.clnu.2019.04.006
M3 - Article
C2 - 31053513
SN - 0261-5614
VL - 39
SP - 976
EP - 984
JO - Clinical Nutrition
JF - Clinical Nutrition
IS - 3
ER -