Jelsma 2013.

Trial name or title	DALI: vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention.
Methods	Randomised controlled trial with a factorial design.
Participants	Pregnant women with gestational age at recruitment < 12 weeks, and more than 18 years of age. Inclusion criteria: pre‐pregnancy BMI (self‐reported weight, measured height) is >= 29 kg/m2), sufficiently fluent in major language of the country of recruitment, being able to be moderately physically active, giving written informed consent, agree to give birth in 1 of the participating hospitals. Exclusion criteria: pre‐existing diabetes, diagnosed with (gestational) diabetes mellitus before randomisation, defined as fasting glucose ≥ 5.1 mmol/L and/or 1‐hour glucose ≥ 10 mmol/L and/or 2‐hour glucose ≥ 8.5 mmol/L at baseline, not able to walk at least 100 metres safely, requirement for complex diets, advanced chronic conditions (e.g. valvular heart disease), significant psychiatric disease, unable to speak major language of the country of recruitment fluently, known abnormal calcium metabolism (hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria) or hypercalciuria detected at screening (0.6 mmol/mmol creatinine in spot morning urine) and twin pregnancy.
Interventions	The design is that of 2 trials with a factorial design: PA, diet, PA & diet, control, vitamin D, PA & diet and placebo, vitamin D & PA & diet, placebo; to compare the impact of increased PA, enhanced nutrition and vitamin D supplementation either alone or in combination on maternal glucose tolerance, maternal weight gain and insulin sensitivity. The doses of vitamin D that will be tested in the dosing study are 500, 1000 and 1500 IU/day. One of these doses will be used in the trial.
Outcomes	Maternal: weight gain during pregnancy, fasting plasma glucose, HbA1c, fasting C peptide, leptin, triglycerides, free fatty acids, high density lipoprotein cholesterol (HDL‐C) and low density lipoprotein cholesterol (LDL‐C), adiponectin 2. 3 beta‐hydroxybutyrate, blood pressure, C‐reactive protein. Infant: neonatal growth, adiposity, adipo‐insular axis, glucose‐insulin axis, electrolyte concentrations, clinical outcomes and hypoxia exposure at birth, biparietal diameter, head circumference, abdominal circumference, femur length and determinants of fetal body composition variables (lean body mass and fat body mass, C‐peptide, glucose, leptin, triglycerides, 3‐ beta‐hydroxybutyric acid, pH and erythropoietin, jaundice, hypocalcaemia, hypomagnesaemia.
Starting date	21/11/2011.
Contact information	Dr David Simmons Addenbrooke's Treatment Centre Hills Road, Cambridge CB2 0QQ UK
Notes	Sponsor: European Union (EU) (Belgium) ‐ Seventh Framework Programme (FP7).