DALI: Vitamin D and Lifestyle Intervention for GDM Prevention: dosing study

Phase 2

Withdrawn

Conditions: gestational diabetes
10018424
10026908

Registration Number: NL-OMON36181

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

* Pre-pregnancy BMI (self-reported weight, measured height) is * 29 kg/m2)
* Aged 18 years or more
* Singleton pregnancy
* Gestational age at recruitment < 12 weeks
* Sufficiently fluent in major language of the country of recruitment
* able to be oderately physically active
* gives written informed consent
* Agree to give birth in one 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 measurement.
* Not able to walk at least 100 meters 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 current or past abnormal calcium metabolism (hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria)
* Hypercalciuria detected at screening (>0.6 mmol/mmol creatinine in spot morning urine) hypercalcaemia detected at screening (>10.6 mg/dl |2.65 mmol/l)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Maternal<br /><br>* Serum vitamin D concentration at term between 50 and 135 nmol/l<br /><br>* Serum calcium * corresponding trimester cut-off<br /><br>* Urinary calcium/creatinine ratio * 0.90 mmol/mmol<br /><br><br /><br>Foetal<br /><br>* Cord blood vitamin D concentration</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Maternal<br /><br>* Weight gain during pregnancy<br /><br>* Fasting plasma glucose<br /><br>* Blood pressure<br /><br><br /><br>Foetal<br /><br>Measured at birth:<br /><br>* Placental weight<br /><br>* Birth weight and length<br /><br>* Head and abdominal circumference<br /><br>* Neonatal body composition<br /><br><br /><br>After birth:<br /><br>* clinical outcomes such as jaundice, hypocalcaemia, neonatal intensive care<br /><br>unit (NICU) admission, respiratory distress </p><br>