DALI: finding the right dose of Vitamin D for obese pregnant wome

• Conditions: Gestational diabetes; MedDRA version: 14.0Level: LLTClassification code 10012606Term: Diabetes mellitus gestationalSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2010-019252-41-AT
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 60

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
• being able to be moderately physically active
• giving written informed consent
• agreeing to give birth in one of the participating hospitals
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• pre-existing diabetes
• diagnosed with (gestational) diabetes mellitus before randomisation
• 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify the optimum dose of Vitamin D cholecalciferol to be supplemented to obese pregnant women in order to reach a target maternal concentration >50 nmol/l.;Secondary Objective: Test procedures for the full trial;Primary end point(s): Maternal:<br>• Serum vitamin D concentration at term = 50 nmol/l; -not to exceed 135 nmol/l<br>• Serum calcium = corresponding trimester cut-off<br>• Urinary calcium/creatinine ratio = 0.90 mmol/mmol<br>Foetal<br>• Cord blood vitamin D concentration<br>;Timepoint(s) of evaluation of this end point: 18-20, 24-28 and 35-37 weeks gestational age

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Maternal:<br>• Weight gain during pregnancy<br>• Fasting plasma glucose<br>• Blood pressure<br>Foetal: <br>• Placental weight<br>• Birth weight and length<br>• Head and abdominal circumference<br>• Neonatal body composition<br>After birth:<br>• clinical outcomes such as jaundice, hypocalcaemia, neonatal intensive care unit (NICU) admission, respiratory distress;Timepoint(s) of evaluation of this end point: 18-20, 24-28 and 35-37 weeks gestational age