title: 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.
abstract: OBJECTIVE
  To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in long-term care facility residents.
  
  
  METHODS
  Double-blind, placebo-controlled clinical trial.
  
  
  METHODS
  One long-term care facility in Pavia, Italy.
  
  
  METHODS
  Forty-three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group) aged 78.3 ± 3.9.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy. mariangela.rondanelli@unipv.it
authors.forename: Mariangela
authors.initials: M
authors.lastname: Rondanelli
authors.forename: Annalisa
authors.initials: A
authors.lastname: Opizzi
authors.forename: Francesca
authors.initials: F
authors.lastname: Monteferrario
authors.forename: Neldo
authors.initials: N
authors.lastname: Antoniello
authors.forename: Raffaele
authors.initials: R
authors.lastname: Manni
authors.forename: Catherine
authors.initials: C
authors.lastname: Klersy
mesh_terms: D000368:Aged; D002492:Central Nervous System Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D007558:Italy; D008134:Long-Term Care; D008274:Magnesium / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008550:Melatonin / Q000009:adverse effects / Q000627:therapeutic use*; D009735:Nursing Homes; D011788:Quality of Life; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D015032:Zinc / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D002492:Central Nervous System Depressants; D008274:Magnesium; D015032:Zinc; D008550:Melatonin