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Will 1600 IU vitamin D prevent gestational diabetes – no, not enough, July 2013

DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial — study protocol

BMC Pregnancy and Childbirth 2013, 13:142 doi:10.1186/1471-2393-13-142
Published: 5 July 2013
Judith GM Jelsma, Mireille NM van Poppel, Sander Galjaard, Gernot Desoye, Rosa Corcoy, Roland Devlieger, Andre van Assche, Dirk Timmerman, Goele Jans, Jurgen Harreiter, Alexandra Kautzky-Willer, Peter Damm, Elisabeth R Mathiesen, Dorte M Jensen, Liselotte Andersen, Fidelma Dunne, Annunziata Lapolla, Graziano Di Cianni, Alessandra Bertolotto, Ewa Wender-Oegowska, Agnieszka Zawiejska, Kinga Blumska, David Hill, Pablo Rebollo, Frank J Snoek and David Simmons

Previous studies indicate that >2,000 IU is needed to prevent normal diabetes. Expect that >3,000 IU will be needed for Gestational Diabetes


Background

Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women.
Methods

Pregnant women at risk of GDM (BMI>=29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, GDM will be excluded (based on IADPSG criteria: fasting glucose<5.1mmol; 1 hour glucose <10.0 mmol; 2 hour glucose <8.5mmol) and women will be randomized to one of the 8 intervention arms using a 2x(2x2) factorial design: ( 1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5kg and either 7 healthy eating 'messages' and/or 5 physical activity 'messages' depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24- -28 weeks, 35- -37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight.


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