The Effect of Melatonin, Magnesium, and Zinc on Primary Insomnia in Long-Term Care Facility Residents in Italy: A Double-Blind, Placebo-Controlled Clinical Trial

Authors

  • Mariangela Rondanelli PhD,

    1. From the *Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, and Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy; Azienda di Servizi alla Persona di Pavia, Nursing Home F. Pertusati, Pavia, Italy; §Unit of Sleep Medicine, IRCCS National Institute of Neurology, C. Mondino Foundation, Pavia, Italy; and Service of Biometry and Clinical Epidemiology, Fondazione IRCCS “Policlinico San Matteo,” Pavia, Italy.
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  • Annalisa Opizzi,

    1. From the *Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, and Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy; Azienda di Servizi alla Persona di Pavia, Nursing Home F. Pertusati, Pavia, Italy; §Unit of Sleep Medicine, IRCCS National Institute of Neurology, C. Mondino Foundation, Pavia, Italy; and Service of Biometry and Clinical Epidemiology, Fondazione IRCCS “Policlinico San Matteo,” Pavia, Italy.
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  • Francesca Monteferrario MD,

    1. From the *Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, and Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy; Azienda di Servizi alla Persona di Pavia, Nursing Home F. Pertusati, Pavia, Italy; §Unit of Sleep Medicine, IRCCS National Institute of Neurology, C. Mondino Foundation, Pavia, Italy; and Service of Biometry and Clinical Epidemiology, Fondazione IRCCS “Policlinico San Matteo,” Pavia, Italy.
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  • Neldo Antoniello MD,

    1. From the *Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, and Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy; Azienda di Servizi alla Persona di Pavia, Nursing Home F. Pertusati, Pavia, Italy; §Unit of Sleep Medicine, IRCCS National Institute of Neurology, C. Mondino Foundation, Pavia, Italy; and Service of Biometry and Clinical Epidemiology, Fondazione IRCCS “Policlinico San Matteo,” Pavia, Italy.
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  • Raffaele Manni MD,

    1. From the *Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, and Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy; Azienda di Servizi alla Persona di Pavia, Nursing Home F. Pertusati, Pavia, Italy; §Unit of Sleep Medicine, IRCCS National Institute of Neurology, C. Mondino Foundation, Pavia, Italy; and Service of Biometry and Clinical Epidemiology, Fondazione IRCCS “Policlinico San Matteo,” Pavia, Italy.
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  • Catherine Klersy MD

    1. From the *Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, and Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy; Azienda di Servizi alla Persona di Pavia, Nursing Home F. Pertusati, Pavia, Italy; §Unit of Sleep Medicine, IRCCS National Institute of Neurology, C. Mondino Foundation, Pavia, Italy; and Service of Biometry and Clinical Epidemiology, Fondazione IRCCS “Policlinico San Matteo,” Pavia, Italy.
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Address correspondence to Mariangela Rondanelli, Department of Applied Health Sciences, Section of Human Nutrition and Dietetics, Faculty of Medicine, University of Pavia, Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona di Pavia, University of Pavia, Via Emilia 12, 27100 Pavia, Italy. E-mail: mariangela.rondanelli@unipv.it

Abstract

OBJECTIVES: To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in long-term care facility residents.

DESIGN: Double-blind, placebo-controlled clinical trial.

SETTING: One long-term care facility in Pavia, Italy.

PARTICIPANTS: Forty-three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group) aged 78.3±3.9.

INTERVENTION: Participants took a food supplement (5 mg melatonin, 225 mg magnesium, and 11.25 mg zinc, mixed with 100 g of pear pulp) or placebo (100 g pear pulp) every day for 8 weeks, 1 hour before bedtime.

MEASUREMENTS: The primary goal was to evaluate sleep quality using the Pittsburgh Sleep Quality Index. The Epworth Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire (LSEQ), the Short Insomnia Questionnaire (SDQ), and a validated quality-of-life instrument (Medical Outcomes Study 36-item Short Form Survey (SF-36)) were administered as secondary end points. Total sleep time was evaluated using a wearable armband-shaped sensor. All measures were performed at baseline and after 60 days.

RESULTS: The food supplement resulted in considerably better overall PSQI scores than placebo (difference between groups in change from baseline PSQI score=6.8; 95% confidence interval=5.4–8.3, P<.001). Moreover, the significant improvements in all four domains of the LSEQ (ease of getting to sleep, P<.001; quality of sleep, P<.001; hangover on awakening from sleep, P=.005; alertness and behavioral integrity the following morning, P=.001), in SDQ score (P<.001), in total sleep time (P<.001), and in SF-36 physical score (P=.006) suggest that treatment had a beneficial effect on the restorative value of sleep.

CONCLUSION: The administration of nightly melatonin, magnesium, and zinc appears to improve the quality of sleep and the quality of life in long-term care facility residents with primary insomnia.

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