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

DALI dosing study of Vitamin D in obese pregnant women - DALI

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019252-41-AT

Enrollment

Registered

2011-07-19

Start date

2011-08-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes MedDRA version: 14.0 Level: LLT Classification code 10012606 Term: Diabetes mellitus gestational System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Biovinci D-Vitamin Product Name: Vitamin D Product Code: Vitamin D Pharmaceutical Form: Tablet INN or Proposed INN: Cholecalciferol CAS Number: 67-97-0 Current Sponsor code: Vitamin D Othe

Eligibility

Sex/Gender

All

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 =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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: • Serum vitamin D concentration at term = 50 nmol/l; -not to exceed 135 nmol/l • Serum calcium = corresponding trimester cut-off • Urinary calcium/creatinine ratio = 0.90 mmol/mmol Foetal • Cord blood vitamin D concentration ;Timepoint(s) of evaluation of this end point: 18-20, 24-28 and 35-37 weeks gestational age	—

Measure

Time frame

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: • Serum vitamin D concentration at term = 50 nmol/l; -not to exceed 135 nmol/l • Serum calcium = corresponding trimester cut-off • Urinary calcium/creatinine ratio = 0.90 mmol/mmol Foetal • Cord blood vitamin D concentration ;Timepoint(s) of evaluation of this end point: 18-20, 24-28 and 35-37 weeks gestational age

—

Secondary

Measure	Time frame
Secondary end point(s): Maternal: • Weight gain during pregnancy • Fasting plasma glucose • Blood pressure Foetal: • 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;Timepoint(s) of evaluation of this end point: 18-20, 24-28 and 35-37 weeks gestational age	—

Measure

Time frame

Secondary end point(s): Maternal: • Weight gain during pregnancy • Fasting plasma glucose • Blood pressure Foetal: • 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;Timepoint(s) of evaluation of this end point: 18-20, 24-28 and 35-37 weeks gestational age

—

Countries

Austria

Contacts

Public ContactTrial Coordinator

Cambridge University Hospitals NHS Foundation Trust

david.simmons@addenbrookes.nhs.uk+441223245151

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026