The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention

No major benefit shown besides vitamin D sufficiency

Rosa Corcoy, Lilian C Mendoza, David Simmons, Gernot Desoye, J M Adelantado, Ana Chico, Roland Devlieger, Andre van Assche, Sander Galjaard, Dirk Timmerman, Annunziata Lapolla, Maria G Dalfra, Alessandra Bertolotto, Jürgen Harreiter, Ewa Wender-Ozegowska, Agnieszka Zawiejska, Alexandra Kautzky-Willer, Fidelma P Dunne, Peter Damm, Elisabeth R Mathiesen & 10 andre Dorte M Jensen, Lise Lotte T Andersen, Mette Tanvig, David J Hill, Judith G Jelsma, Frank J Snoek, Harald Köfeler, Martin Trötzmüller, Paul Lips, Mireille N M van Poppel

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

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.

OriginalsprogEngelsk
TidsskriftClinical Nutrition
ISSN0261-5614
DOI
StatusE-pub ahead of print - 11. apr. 2019

Fingeraftryk

Gestational Diabetes
Randomized Controlled Trials
Fasting
Vitamins
Insulin Resistance
Serum
Placebos
Multicenter Studies
Weight Gain
Pregnant Women
Linear Models
Body Mass Index
Logistic Models
Regression Analysis
Weights and Measures

Citer dette

Corcoy, Rosa ; Mendoza, Lilian C ; Simmons, David ; Desoye, Gernot ; Adelantado, J M ; Chico, Ana ; Devlieger, Roland ; van Assche, Andre ; Galjaard, Sander ; Timmerman, Dirk ; Lapolla, Annunziata ; Dalfra, Maria G ; Bertolotto, Alessandra ; Harreiter, Jürgen ; Wender-Ozegowska, Ewa ; Zawiejska, Agnieszka ; Kautzky-Willer, Alexandra ; Dunne, Fidelma P ; Damm, Peter ; Mathiesen, Elisabeth R ; Jensen, Dorte M ; Andersen, Lise Lotte T ; Tanvig, Mette ; Hill, David J ; Jelsma, Judith G ; Snoek, Frank J ; Köfeler, Harald ; Trötzmüller, Martin ; Lips, Paul ; van Poppel, Mireille N M. / The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention : No major benefit shown besides vitamin D sufficiency. I: Clinical Nutrition. 2019.
@article{5ace880568b243a3a1708c049577ba00,
title = "The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention: No major benefit shown besides vitamin D sufficiency",
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",
author = "Rosa Corcoy and Mendoza, {Lilian C} and David Simmons and Gernot Desoye and Adelantado, {J M} and Ana Chico and Roland Devlieger and {van Assche}, Andre and Sander Galjaard and Dirk Timmerman and Annunziata Lapolla and Dalfra, {Maria G} and Alessandra Bertolotto and J{\"u}rgen Harreiter and Ewa Wender-Ozegowska and Agnieszka Zawiejska and Alexandra Kautzky-Willer and Dunne, {Fidelma P} and Peter Damm and Mathiesen, {Elisabeth R} and Jensen, {Dorte M} and Andersen, {Lise Lotte T} and Mette Tanvig and Hill, {David J} and Jelsma, {Judith G} and Snoek, {Frank J} and Harald K{\"o}feler and Martin Tr{\"o}tzm{\"u}ller and Paul Lips and {van Poppel}, {Mireille N M}",
note = "Copyright {\circledC} 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.",
year = "2019",
month = "4",
day = "11",
doi = "10.1016/j.clnu.2019.04.006",
language = "English",
journal = "Clinical Nutrition",
issn = "0261-5614",
publisher = "Elsevier",

}

Corcoy, R, Mendoza, LC, Simmons, D, Desoye, G, Adelantado, JM, Chico, A, Devlieger, R, van Assche, A, Galjaard, S, Timmerman, D, Lapolla, A, Dalfra, MG, Bertolotto, A, Harreiter, J, Wender-Ozegowska, E, Zawiejska, A, Kautzky-Willer, A, Dunne, FP, Damm, P, Mathiesen, ER, Jensen, DM, Andersen, LLT, Tanvig, M, Hill, DJ, Jelsma, JG, Snoek, FJ, Köfeler, H, Trötzmüller, M, Lips, P & van Poppel, MNM 2019, 'The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention: No major benefit shown besides vitamin D sufficiency', Clinical Nutrition. https://doi.org/10.1016/j.clnu.2019.04.006

The DALI vitamin D randomized controlled trial for gestational diabetes mellitus prevention : No major benefit shown besides vitamin D sufficiency. / Corcoy, Rosa; Mendoza, Lilian C; Simmons, David; Desoye, Gernot; Adelantado, J M; Chico, Ana; Devlieger, Roland; van Assche, Andre; Galjaard, Sander; Timmerman, Dirk; Lapolla, Annunziata; Dalfra, Maria G; Bertolotto, Alessandra; Harreiter, Jürgen; Wender-Ozegowska, Ewa; Zawiejska, Agnieszka; Kautzky-Willer, Alexandra; Dunne, Fidelma P; Damm, Peter; Mathiesen, Elisabeth R; Jensen, Dorte M; Andersen, Lise Lotte T; Tanvig, Mette; Hill, David J; Jelsma, Judith G; Snoek, Frank J; Köfeler, Harald; Trötzmüller, Martin; Lips, Paul; van Poppel, Mireille N M.

I: Clinical Nutrition, 11.04.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

N1 - Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

PY - 2019/4/11

Y1 - 2019/4/11

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/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.

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/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.

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

JO - Clinical Nutrition

JF - Clinical Nutrition

SN - 0261-5614

ER -