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

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.

See Vitamin D Life

• Overview Diabetes and vitamin D
• 300,000 IU injection loading dose of vitamin D3 stopped gestational diabetes in RCT – Oct 2011
• Insulin resistance during pregnancy improved with 50,000 IU of vitamin D every 2 weeks – RCT April 2013 = 3,500 IU average daily
• Overview Pregnancy and vitamin D which has the following summary
  

  IU	Cumulative Benefit	Blood level	Cofactors	Calcium	$*/month
  200	Better bones for mom with 600 mg of Calcium	6 ng/ml increase	Not needed	No effect	$0.10
  400	Less Rickets (but not zero with 400 IU) 3X less adolescent Schizophrenia Fewer child seizures	20-30 ng/ml	Not needed	No effect	$0.20
  2000	2X More likely to get pregnant naturally/IVF 2X Fewer dental problems with pregnancy 8X less diabetes 4X fewer C-sections (>37 ng) 4X less preeclampsia (40 ng vs 10 ng) 5X less child asthma 2X fewer language problems age 5	42 ng/ml	Desirable	< 750 mg	$1
  4000	2X fewer pregnancy complications 2X fewer pre-term births	49 ng/ml	Should have cofactors	< 750 mg	$3
  6000	Probable: larger benefits for above items Just enough D for breastfed infant More maternal and infant weight		Should have cofactors	< 750 mg	$4

• [https://www.vitad.org/Search+Results?hl=en&oe=UTF-8&ie=UTF-8&btnG=Google+Search&googles.x=0&googles.y=0&q=%22gestational+diabetes%22&domains=vitad.org&sitesearch=vitad.org|Search Vitamin D Life for "Gestational Diabetes] 114 items as of July 2013
• Gestational diabetes 60 percent more likely below 20 ng of vitamin D – meta-analysis Feb 2012