E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal affective disorder. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
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 | 10039775 |
E.1.2 | Term | Seasonal affective disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric 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 |
To investigate whether or not vitamin D supplementation is better than placebo in preventing symptoms of depression in health service staff. |
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E.2.2 | Secondary objectives of the trial |
To investigate whether or not there is a correlation between symptoms of depression and Winter depression in health service staff and the plasma concentration of 25-hydroxy-vitamin D3. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Employed at either Sydvestjysk Sygehus or Psykiatrien i Region Syddanmark, Esbjerg, Denmark. Seasonal Pattern Assessment Questionnaire (SPAQ-SAD) score above 11. Negative urine hCG test in women of childbearing potential. |
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E.4 | Principal exclusion criteria |
Fulfilled ICD-10 criteria for diseases F20-29 and F31. Sarcoidosis. Tuberculosis. Decreased kidney function measured as estimated GFR (4-variable MDRD equation) < 60 ml per minute. Increased plasma ionized calcium concentration above 1,40 mmoles per liter. Increased plasma phosphate concentration above 1,50 mmoles per liter for women, above 1,60 mmoles per liter for men below 50 years of age and above 1,35 mmoles per liter for men equal to and above 50 years of age. Plasma concentration of 25-hydroxy-vitamin D3 below 10 nmoles per liter or above 160 nmoles per liter. Hyperparathyroidism measured as PTH concentration above 9,2 pmoles per liter. Pregnancy or wanted pregnancy. Nursing women. Already participated in the trial. Daily intake of vitamin D3 above 10 micrograms. Allergy towards tablet contents. No informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
World Health Organization Five Well Being Index (WHO-5) score. Depression Self-Assessment Inventory (SIGH-SAD-SA) score. Plasma concentration of 25-hydroxy-vitamin D3.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0 and 3 months for WHO-5 and SIGH-SAD. 0 and 3 months for 25-hydroxy-vitamin D3. |
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E.5.2 | Secondary end point(s) |
Correlation between SIGH-SAD-SA and WHO-5 score and the plasma concentration of 25-hydroxy-vitamin D3 in the two groups. Whether or not the total number of sick days are fewer in the vitamin D receiving group. |
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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 | No |
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 | 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.8.2.4 | 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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Provided in the protocol. |
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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 |