E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012606 |
E.1.2 | Term | Diabetes mellitus gestational |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Test procedures for the full trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | 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
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
18-20, 24-28 and 35-37 weeks gestational age |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
18-20, 24-28 and 35-37 weeks gestational age |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last recruited woman giving birth. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |