E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subjects with serum 25-hydroxyvitamin D < 35 nmol/L will be included and the effect of vitamin D supplementation versus placebo tested regarding cardiovascular risk factors |
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E.1.1.1 | Medical condition in easily understood language |
subjects with serum 25-hydroxyvitamin D < 35 nmol/L will be included and the effect of vitamin D supplementation versus placebo tested regarding cardiovascular risk factors |
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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 see the effect of vitamin D supplementatin on cardiovascular risk factors |
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E.2.2 | Secondary objectives of the trial |
To see the effect of vitamin D supplementatin on cardiovascular risk factors |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
males and females 20 - 80 yearts
participated in the 7th Tromsø study
low serum 25OHD (< 35 nmol/L) |
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E.4 | Principal exclusion criteria |
- subjects allergic to nuts (the study capsules contain peanut oil)
- subjects with primary hyperparathyroidism
- granulomatous diseases (sarcoidosis, tuberculosis, Wegner’s granulomatosis)
- reduced kidney function (creatinine > 130 μmol/L in males and 120 μmol/L in females)
- systolic BP > 174 mmHg, diastolic BP > 104 mmHg,
- diabetes (fasting blood glucose > 6.9 mmol/L and/or HbA1c > 6.5 %)
- renal stones the last 5 years
- subjects who use solarium on a regular basis (more than twice a month on average)
- subjects who plan holiday(s) in tropical areas (or Mediterranean during the summer months) for more than two weeks
- subjects with BDI score higher than 29
- subjects with clinical signs of proximal myopathy (problems with standing up from chair or walking stairs)
- subjects seriously ill and unfit for participation in a clinical study (as judged by one of the study doctors)
- subjects using vitamin D supplements exceeding 800 IU per day or active vitamin D drugs (Rocaltrol or Etalpha)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints will be the difference in change between the vitamin D and placebo group in CVD risk factors (BP, lipid profile, insulin resistance) after three months. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at end of study after 3 months |
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E.5.2 | Secondary end point(s) |
- Difference in change in muscle strength (hand-grip, quadriceps, biceps) after three months
- Difference in BDI score after three months
- Difference in cognitive function tests after three months
- Difference in PWV, augmentation index (AIX), and subendocardial viability ratio (SEVR) after three months
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at end of study after 3 months |
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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 | 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) | 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 | 1 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |