E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Randomised, placebo controlled, parallel group, double blinded study to investigate if oral supplementation of vitamin D will improve vascular function and metabolic and inflammatory parameters in patients who have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. We will investigate arterial stiffness and endothelial function in this group of patients. |
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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 |
Does high dose oral vitamin D improve the elasticity of the blood vessels in patients with ME/CFS?
The answer to this question will show whether vitamin D has any beneficial effect on blood vessel elasticity and therefore on the overall state of the cardiovascular system. The more elastic a blood vessel, then the healthier it is considered to be. |
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E.2.2 | Secondary objectives of the trial |
Does high dose Vitamin D improve the health of the blood vessels, reduce inflammation and affect other blood tests that may be associated with poor blood vessel function?
Is the XMRV virus present in this population of ME/CFS patients and if so does it relate to markers of vascular function? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients diagnosed with ME/CFS [fulfil the Fukuda (1994) and Canadian (2003)criteria]
Serum 25(OH)D levels <75 nmol/l |
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E.4 | Principal exclusion criteria |
1.Patients not diagnosed by consultant with ME/CFS 2.Patients already taking Vitamin D supplements (fish oils will be permitted) 3.Estimated GFR < 40 mls/min (by MDRD4 method) 4.Adjusted serum calcium <2.15 or > 2.60 mmol/L 5.LFTs > 3x upper limit of normal 6.Known metastatic malignancy 7.History of Kidney stones 8.History of sarcoidosis or Osteoporosis 9.Lying systolic BP < 80 mm Hg 10.Pregnant, lactating or of childbearing age and not taking reliable contraception 11.Patients diagnosed with psychiatric disorder within the past five years 12.Patients diagnosed with schizophrenia, mania, substance abuse/dependence, or an eating disorder at any time 13.Patients with other known organic cause for their symptoms 14.Unable to give written informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in arterial stiffness between baseline and six months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.3 |
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 | 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 | Information not present in EudraCT |
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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Last visit of the last randomised participant. |
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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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |