Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift

Study Overview
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Brief Summary
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The general aim of this study is to assess the effects of Pharmaton® Caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts

Official Title
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An Evaluation of the Effects of Pharmaton® Caplets Film-coated Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shifts: a Double-blind, Placebo Controlled Pilot Trial

Conditions
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Sleep Disorders, Circadian Rhythm

Intervention / Treatment
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* Drug: Pharmaton® Caplets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female nurses and nursing auxiliaries working night shift Age range: 20 to 45 inclusive BMI range: 18-30 Negative pregnancy test for females Subjects must be free of any clinically significant disease or condition that required a physician's care and/or was to interfere with study evaluation and procedures Clinical laboratory tests within normal limits or, if out of normal range, clinically acceptable to the investigator Negative urine drug screen for drugs at screening Subjects must be willing to give informed consent prior to study enrolment and be able to adhere to restrictions and examination schedules Exclusion Criteria: Any serious disorder that may interfere with his/her participation to the trial and the evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.) and/or treatment with chronic medication Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation) Individuals drinking more than 40 g alcohol/day (glass of 12.5 cl of wine 10° = 12 g; glass of 4 cl of aperitif 42° = 17 g; glass of 25 cl of beer 3° = 7.5 g; glass of 25 cl of beer 6° = 15 g); Alcohol and drug abuse according to Diagnostic and Statistic Manual, Version IV (DSM-IV) Individuals drinking more that 6 cups of coffee or tea/day Individuals smoking more than 10 cigarettes/day Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine Device (IUD), sterilization) Pregnancy and/or lactation Relevant allergy or known hypersensitivity to the investigational product or its excipients Individuals taking or having taken recently other vitamins and minerals supplementation Individuals with a current disorder likely to modify EEG recordings and/or computerized cognitive testing Individuals having a history of cancer Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial Individuals without health insurance

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaton® Caplets<br> | Drug: Pharmaton® Caplets<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift) |  | at day 77 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram) |  | up to day 77 | 
| Assessment of spontaneous Electroencephalogram (EEG) and event related potentials |  | up to day 77 | 
| Assessment of Sleep-Electroencephalogram parameters |  | Day -1, Day 1, Day 77 | 
| Evaluation of Quality of life scales |  | up to day 77 | 
| Evaluation of Sleep by Visual Analogue Scale (VAS) |  | up to day 77 | 
| Assessment of 24-hours holter Electrocardiogram (ECG) |  | Day -1, Day1, Day 77 | 
| Assessment of urinary cortisol levels |  | Day -1, Day1, Day 77 | 
| Number of patients with adverse events |  | up to 3 months | 
| Assessment of tolerability by investigator on a 4-point scale |  | at day 77 | 
| Assessment of tolerability by subject on a 4-point scale |  | Day 41, Day 77 |