TY - JOUR
T1 - The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention
T2 - 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, Jürgen
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.
PY - 2020/3
Y1 - 2020/3
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
U2 - 10.1016/j.clnu.2019.04.006
DO - 10.1016/j.clnu.2019.04.006
M3 - Journal article
C2 - 31053513
AN - SCOPUS:85064956408
SN - 0261-5614
JO - Clinical Nutrition
JF - Clinical Nutrition
ER -
