Effects of magnesium on insomnia

Not Applicable

Conditions: Insomnia.
A condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time, including difficulty falling asleep, difficulty staying asleep, or early final wakening.

Registration Number: IRCT201109057479N1

Lead Sponsor: ational nutrition and food technology research institute - Shahid Beheshty university of medical sc

Brief Summary: BACKGROUND: Nearly 50% of older adults have insomnia, with difficulty in getting to sleep, early awakening, or feeling unrefreshed on waking. With aging, several changes occur that can place one at risk for insomnia, including age-related changes in various circadian rhythms, environmental and lifestyle changes, and decreased nutrients intake, absorption, retention, and utilization. The natural N-methyl-D-aspartic acid (NMDA) antagonist and GABA agonist, Mg(2+), seems to play a key role in the regulation of sleep. The objective of this study was to determine the efficacy of magnesium supplementation to improve insomnia in elderly. MATERIALS AND METHODS: A double-blind randomized clinical trial was conducted in 46 elderly subjects, randomly allocated into the magnesium or the placebo group and received 500 mg magnesium or placebo daily for 8 weeks. Questionnaires of insomnia severity index (ISI), physical activity, and sleep log were completed at baseline and after the intervention period. Anthropometric confounding factors, daily intake of magnesium, calcium, potassium, caffeine, calories form carbohydrates, and total calorie intake, were obtained using 24-h recall for 3 days. Blood samples were taken at baseline and after the intervention period for analysis of serum magnesium, renin, melatonin, and cortisol. Statistical analyses were performed using SPSS19 and P values < 0.05 were considered as statistically significant. RESULTS: No significant differences were observed in assessed variables between the two groups at the baseline. As compared to the placebo group, in the experimental group, dietary magnesium supplementation brought about statistically significant increases in sleep time (P = 0.002), sleep efficiency (P = 0.03), concentration of serum renin (P < 0.001), and melatonin (P = 0.007), and also resulted in significant decrease of ISI score (P = 0.006), sleep onset latency (P = 0.02) and serum cortisol concentration (P = 0.008). Supplementation also resulted in marginally between-group significant reduction in early morning awakening (P = 0.08) and serum magnesium concentration (P = 0.06). Although total sleep time (P = 0.37) did not show any significant between-group differences. CONCLUSION: Supplementation of magnesium appears to improve subjective measures of insomnia such as ISI score, sleep efficiency, sleep time and sleep onset latency, early morning awakening, and likewise, insomnia objective measures such as concentration of serum renin, melatonin, and serum cortisol, in elderly people.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 46

Inclusion Criteria

Inclusion Criteria: Willing to Cooperate; Age 60-75 years; Having Insomnia according to ISI and Sleep-log questionnaires; Dietary intake of Magnesium under 75% RDA; Serum Mg level under 0.95mmol/L.

Exclusion Criteria

BMI higher than 35 kg/m2; Having alcohol or drug abuse; Having psychiatric disorders; Severe depression or recent stress; Having Transmeridian trip during last 6 weeks; Not willing to cooperate; Using loop diuretics, Cyclosporine, Digoxin, Amphotericin, Hormone replacement therapy; Having renal diseases, acute heart failure, restless legs syndrome, acute Apnea; Not using Mg supplement or placebo

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia severity index. Timepoint: Baseline and after the intervention period. Method of measurement: ISI questionnaire.;Sleep duration. Timepoint: Baseline and after the intervention period. Method of measurement: Sleeplog questionnaire.;Total Serum Magnesium. Timepoint: Baseline and after the intervention period. Method of measurement: Atomic absorption spectrophotometry.;Serum Cortisol. Timepoint: Baseline and after the intervention period. Method of measurement: ELISA.;Serum Renin. Timepoint: Baseline and after the intervention period. Method of measurement: ELISA.;Serum Melatonin. Timepoint: Baseline and after the intervention period. Method of measurement: ELISA.

Secondary Outcome Measures