E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of the study is to increase vitamin D concentrations respectively to keep it on high level by supplementing with cholecalciferol in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy. |
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E.1.1.1 | Medical condition in easily understood language |
Vitamin D concentration, parameters of inflammation, bone turnover, insulin resistance and depression score are expected to improve, due to supplementation of a loading dose of vitamin D. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
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 test whether administering up to three doses of 100 000 IU vitamin D3 in the first month postoperatively (loading dose), followed by 3420 IU/day (intervention group LMD) in bariatric patients will increase significantly 25-hydroxyvitamin D levels 24 weeks after surgery, compared with a control group receiving placebo, followed by the standard daily doses of 3420 IU/ day (control group ST). |
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E.2.2 | Secondary objectives of the trial |
• Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l in both groups (placebo and intervention) • Prevalence of vitamin D deficiency in morbidly obese bariatric patients • The expression of the 25-hydroxylases: CYP27A1, CYP2R1, CYP2J2, CYP3A4, CYP2C11, CYP27B1 (1α-hydroxylase), 24-hydroxylase (CYP24A1) and VDR genes by adipocytes in morbidly obese patients • Measurement of vitamin D concentrations in two adipose tissue depots, visceral (VAT) and subcutaneous adipose tissue (SAT), and liver tissue at the time of omega loop bypass surgery (vitamin D storage in adipose and liver tissue) • Change in body fat mass: by Dual energy X-Ray absorptiometry DEXA • Change in blood pressure: systolic and diastolic (mmHg) • Change in food intake: 5-day food record and Mediterranean Score • Change in depression symptoms: Beck Depression Inventory (BDI Score) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men and women over the age of 18 and under 100 years Planned omega loop bypass surgery 25-OHD < 75 nmol/l BMI > 40 or ≥ 35 kg/m2 with co-morbidities e.g. diabetes mellitus and hypertension Body weight < 150 kg (due to limitation of DEXA measurement) Capability to consent
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E.4 | Principal exclusion criteria |
Another planned form of bariatric surgery Hypercalcemia (calcium > 2.63 mmol/l) or hypocalcemia (calcium < 1.75 mmol/l) Renal insufficiency (creatinine > 133 μmol/l or GFR < 50 ml/min) Primary hyperparathyroidism Malignancy infection e.g. human immunodeficiency virus (HIV) Medical conditions requiring daily calcium supplements or antacid use Known hypersensitivity to cholecalciferol No capability to consent Imprisoned persons
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E.5 End points |
E.5.1 | Primary end point(s) |
25-OHD levels (nmol/l) after 24 weeks measured in intervention and control group, adjusting for the baseline value as covariate. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Changes after 24 weeks between intervention and control group: • Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l • Prevalence of vitamin D deficiency • Co-morbidities, • Prescribed medication, • Body weight, body composition (lean body mass and fat), • Vital signs (blood pressure), • Laboratory parameter, • Depression symptoms (BDI score), • Bone mineral density and structure (DEXA and qCT), • Liver condition (FibroScan® and CAPTM), • Dietary assessment. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |