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.
Conditions
Interventions
Intervention 1: Intervention group will receive 250 mg magnesium supplement tablets.
Bid for 8 weeks. Intervention 2: Control group will receive 250 mg placebo tablets containing starch.
Bid for 8 wee
Treatment - Drugs
Intervention group will receive 250 mg magnesium supplement tablets.
Bid for 8 weeks.
Control group will receive 250 mg placebo tablets containing starch.
Bid for 8 weeks.
Sponsors
National nutrition and food technology research institute - Shahid Beheshty university of medical sc
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Total energy intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days.;Carbohydrate intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days.;Dietary Calcium intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days.;Dietary potassium,k intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days.;Dietary caffeine intake. Timepoint: Baseline and after the intervention period. Method of measurement: 24-hrs recall for 3-days.;Weight. Timepoint: Baseline and after the intervention period. Method of measurement: Scale.;Physical activity. Timepoint: Baseline and after the intervention period. Method of measurement: Physical activity questionnaire.;Depression. Timepoint: Baseline and after the intervention period. Method of measurement: SCL-90 questionnaire.;Quality of life. Timepoint: Baseline and after the intervention period. Method of measurement: GHQ-28.;Loose stool. Timepoint: Baseline and after the intervention period. Method of measurement: Asking. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehnood Abbasi
National nutrition and food technology research institute-Shahid Beheshti University of Medical Scie
Outcome results
None listed