E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children and young adults with HIV infection and hypovitaminosis D. |
Pazienti minori e giovani adulti HIV+ con ipovitaminosi D. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047626 |
E.1.2 | Term | Vitamin D deficiency |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10047635 |
E.1.2 | Term | Vitamin related disorders |
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 |
A single dose of high concentrated (100.000 UI) colecalciferol, orally administered every 3 months, during 12 months,
to HIV infected patients selected for insufficient values of plasmatic vitamin-D, might re-establish normal vitamin-D levels considered for age (>20 ng/ml for those <18 years; > 30 ng/ml for those > 18 years). |
Una supplementazione costante con una singola dose di colecalciferolo ad elevata concentrazione (100.000 U.I.) ogni 3 mesi, per 12 mesi, in pazienti HIV-infetti con insufficienti valori plasmatici di vitamina D possa ripristinare i valori di normalita' considerati per l’eta' (>20 ng/ml se eta' <18; > 30 ng/ml se eta' > 18). |
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E.2.2 | Secondary objectives of the trial |
Secondary objective will be the grade of immunoactivation and values of bone formation and reabsorption, examined through specific immunologic and biochemical markers. |
Obiettivo secondario dello studio e' l’indagine dell’associazione tra i valori plasmatici di 25-OH vitamina D e i markers di attivazione immunologica prima, durante e dopo un intervento di supplementazione. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age between 8 and 26 years at the enrolment
• Plasma vitamin D values < 20 ng/ml for subjects < 18 years
• Plasma vitamin D values < 30 ng/ml for subjects > 18 years
• Signed informed consent |
• Eta' compresa fra e 8 e 26 anni al momento del reclutamento
• Valori plasmatici di vitamina D < 20 ng/ml nei soggetti < 18 anni,
• Valori plasmatici di vitamina D < 30 ng/ml nei soggetti > 18 anni.
• Firma del consenso informato per la partecipazione allo studio |
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E.4 | Principal exclusion criteria |
• Hyperparathyroidism, defined as vitamin D3 < than normal levels (< 20 ng/ml for those <18 years; < 30 ng/ml for those > 18 years) and PTH > 65 pg/ml.
• Hyper or Hypocalcemia: range for age= 9.0-11.0 mg/dL (8-16 years); 8.5 -10.5 mg/dL (> 16 years);
• African American ethnicity, to avoid bias determined by the different skin vitamin D3 synthesis promoted by sun exposure.
• Every supplementation with Vitamin D or derived products taken during the 12 months previous to the enrollment.
• Every drug or substance capable to alter Vitamin D and PTH absorption and/or metabolism, excluding antiretroviral drugs.
• Severe pathologic associated conditions such as tumoral, renal, cardiovascular or haematological pathologies. |
• Riscontro di iperparatiroidismo, ovvero vitamina D inferiore alla norma (< 20 ng/ml se < 18 anni o < 30 ng/ml se > 18 anni ) e PTH > 65 pg/ml.
• Iper o ipocalcemia: range per eta'= 9.0-11.0 mg/dL (8-16 anni); 8.5 -10.5 mg/dL (> 16 anni);
• Razza afroamericana per evitare bias legati alla diversa sintesi cutanea di vitamina D3 in risposta all’esposizione solare.
• Qualsiasi supplementazione con vitamina D o di suoi derivati nei 12 mesi antecedenti lo studio.
• Qualsiasi assunzione di farmaci o sostanze in grado di alterare l’assorbimento ed il metabolismo della vitamina D e del PTH, con l’esclusione dei farmaci per il trattamento dell’HIV.
• Gravi condizioni cliniche associate quali malattie neoplastiche, renali, cardiovascolari, ematologiche. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the percentage of patients with hypovitaminosis D at 12 months. |
L’outcome primario sara' la percentuale dei pazienti con ipovitaminosi D al 12° mese. |
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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 | No |
E.6.3 | Therapy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
immunomodulazione/regolazione metabolismo osseo. |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 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 | 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
| |
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 | 13 |
E.8.9.1 | In the Member State concerned days | 0 |