gestational diabetes
Conditions
Interventions
The vitamin D supplements (Biovinci) used in this dosing study will be provided
by Pharma-Vinci A/S (Denmark). Three doses are available (500, 1000 and 1500
IU/tablet) that are indistinguishable fro
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal * Serum vitamin D concentration at term between 50 and 135 nmol/l * Serum calcium * corresponding trimester cut-off * Urinary calcium/creatinine ratio * 0.90 mmol/mmol Foetal * Cord blood vitamin D concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal * Weight gain during pregnancy * Fasting plasma glucose * Blood pressure Foetal Measured at birth: * Placental weight * Birth weight and length * Head and abdominal circumference * Neonatal body composition After birth: * clinical outcomes such as jaundice, hypocalcaemia, neonatal intensive care unit (NICU) admission, respiratory distress | — |
Countries
Netherlands
Outcome results
None listed