Vitamin D and Lifestyle Intervention for Gestational Diabetes Mellitus
Research type
Research Study
Full title
Vitamin D and Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention - A European multicentre, randomised trial: Vitamin D limb. Short title: DALI - Vitamin D.
IRAS ID
115769
Contact name
David Simmons
Contact email
Sponsor organisation
Vrije Universiteit Medisch Centrum
ISRCTN Number
ISRCTN70595832
Research summary
Type 2 diabetes (T2D) is increasing worldwide and Gestational Diabetes Mellitus (GDM) is now recognised as an important contributor to this increase in two ways. Firstly, women with a history of GDM are significantly more likely to go on to develop T2D; secondly, the baby exposed to GDM in-utero is predisposed to diabetes and obesity. Strategies to prevent this factor in the increase of diabetes are urgently needed.
The study will compare the impact of Vitamin D (1600iu daily) in conjunction with lifestyle changes on reducing the risk of developing GDM. 440 women will be recruited across 10 sites in Europe (average 44 per site) and randomised into four groups:
Vitamin D with usual lifestyle advice;
Placebo with usual lifestyle advice;
Vitamin D and physical activity and healthy eating;
Placebo and physical activity and healthy eating.
This study follows a pilot study which tested trial methodology and process, and the lifestyle limb of the main study. The latter is well underway currently. Minimal changes to the protocol only have been required.
Each participant is followed for a period of approximately 7 months. Recruitment takes place between before 20 weeks of pregnancy and baseline measures and blood samples and questionnaires are done. Further visits with measures, blood tests and questionnaires and with the addition of ultrasound scans take place at around 28 and 36 weeks of pregnancy. Following birth blood tests and baby measures are done and placenta and cord blood samples obtained.
The lifestyle interventions are delivered by a coach through motivational interviewing techniques soon after the study entry visit until shortly before the third visit at 35 to 37 weeks.
Vitamin D 1600 iu/day or placebo will be taken by the woman from the Entry visit until birth. Compliance will be checked by pill-counting at each visit. Researchers will be blinded to the vitamin/placebo.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0318
Date of REC Opinion
7 Nov 2013
REC opinion
Further Information Favourable Opinion