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

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

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

Study Overview

• Status: Completed
• Conditions: Sleep Disorders, Circadian Rhythm
• Intervention / Treatment: Drug: Placebo; Drug: Pharmaton® Caplets

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Pharmaton® Caplets	Drug: Pharmaton® Caplets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): January 1, 2001

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 1114.11