E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with primary or secondary immunodeficiencies and/or patients who have an increased incidence of airborn infections more than 42 infectionsday /year. |
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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 |
To investigate if supplement of vitamine D3- to patients who suffers from immunodeficiencies or an increased frequency of infections -leads to a decreased frequency of airborne infections. |
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E.2.2 | Secondary objectives of the trial |
To investigate if vitamine D3 supplement also can lead to a local increase of immunoproteins in mucous membrane. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Healthy volunteers and vitamin D3 supplement. Date:2009-09-24 version 1.0 Primary objective: Determination and clarification of plasma concentration of colecalciferol for safety reasons. Background: We intend to investigate the plasma concentration of cholecalciferol in a"pilotstudy" on 10 healthy volunters. The subjects will be examined by a physcian according to orginal protocol including bloodsamples. If screening procedurs and examinations is OK, the subjects will be given 4000 IU of Vitamin D3 (i.e Vigantol Oil, 8 drops/day) in a consecutive manner of 30 days. Plasma concentration of cholecalciferol and nasopharynx samples will be measured at day "0" and at day "30". The patients will given the same patientinformation and sign the informed consent as in the original protocol. We will perhaps also obtain information regarding the original trial and work out the logistics and the managment more thoroughly. |
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E.3 | Principal inclusion criteria |
1. patients (men and women) aged 18-75with a documented immunodeficiency order IgA IgG or subclass defiency as defined as: hypogammaglobulinemia AND a history of increased airborne infections > 42 days of infections /year 2. patient (men and women) 18-75 years old with an increased frequency of airborne infections i.e. > 42days of infection a year but with none of the above stated deficiencies. 3. patients who accepts to make a daily record of their infections diseasesnuances in a standarized questionnaire form ("infections diary") 4. plasma concentrations of 25 (OH) D3 vitamine D3 < 175nM 5. signed informed consent 6. patients must be listed in the immunodefience unit for at least 1 year ahead
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E.4 | Principal exclusion criteria |
1. patients with less than 42 days of infections a year 2. patients has a ongoing antibiotic treatment 3. patients has clinical signs of hypercalcemia AND/OR verified hypercalcemia by biochemistry of hypercalcemia (>2.5mmol/L) 4. patients has clinical signs of change in parathyroidhormone (PTH >65ng/L) AND/OR verified by biochemistry 5. patients cannot fill in the infection questionnaire 6. patient are not expected to survive more than one year 7. patient has participated in another clinical trial within the last 6 months
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E.5 End points |
E.5.1 | Primary end point(s) |
The frequency of airborne infections |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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.8.3 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 31 |