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Effects of magnesium supplementation on insomnia in the elderly

Protocol summary

Summary
The current study is a randomized, double-blind, placebo-controlled trial to evaluate the effects of magnesium supplementation on insomnia in the elderly. Subjects consist of volunteers: range 60-75 years, with a clinical diagnosis of insomnia, dietary magnesium intake lower than 75% of RDA and total serum magnesium lower than 0.95 mmol/L. Reasons for the exclusion from the study is: body mass index higher than 35 kg/m2, history of psychiatric disorders, severe depression or recent stressful life events, alcohol or substance abuse, a trans-meridian flight during last 6 weeks, diuretics use and hormone replacement therapy, including renal failure,acute heart failure, restless legs syndrome and acute apnea. 46 subjects randomly will be allocated into the magnesium or the placebo group and receiving 250 mg magnesium oxide or placebo twice daily for 8 weeks. In order to evaluate the effect of supplementation, insomnia severity index, sleep time, total serum magnesium, serum renin, serum cortisol, serum melatonin will be measured at baseline and after the intervention period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109057479N1
Registration date: 2011-09-15, 1390/06/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-09-15, 1390/06/24
Registrant information
Name
Behnood Abbasi
Name of organization / entity
Shahid Beheshti university of medical sciences-National nutrition and food technology research insti
Country
Iran (Islamic Republic of)
Phone
+98 21 8870 4487
Email address
b.abbasi@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
Research project of National nutrition and food technology research institute - Shahid Beheshty university of medical sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of magnesium supplementation on insomnia in the elderly
Public title
Effects of magnesium on insomnia
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti university of medical sciences
Street address
Velenjak Street, Shahid Chamran Highway.
City
Tehran
Postal code
1985717443
Approval date
2011-08-06, 1390/05/15
Ethics committee reference number
041400

Health conditions studied

1

Description of health condition studied
Insomnia
ICD-10 code
F51.0
ICD-10 code description
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.

Primary outcomes

1

Description
Insomnia severity index
Timepoint
Baseline and after the intervention period
Method of measurement
ISI questionnaire

2

Description
Sleep duration
Timepoint
Baseline and after the intervention period
Method of measurement
Sleeplog questionnaire

3

Description
Total Serum Magnesium
Timepoint
Baseline and after the intervention period
Method of measurement
Atomic absorption spectrophotometry

4

Description
Serum Cortisol
Timepoint
Baseline and after the intervention period
Method of measurement
ELISA

5

Description
Serum Renin
Timepoint
Baseline and after the intervention period
Method of measurement
ELISA

6

Description
Serum Melatonin
Timepoint
Baseline and after the intervention period
Method of measurement
ELISA

Secondary outcomes

1

Description
Total energy intake
Timepoint
Baseline and after the intervention period
Method of measurement
24-hrs recall for 3-days

2

Description
Carbohydrate intake
Timepoint
Baseline and after the intervention period
Method of measurement
24-hrs recall for 3-days

3

Description
Dietary Calcium intake
Timepoint
Baseline and after the intervention period
Method of measurement
24-hrs recall for 3-days

4

Description
Dietary potassium,k intake
Timepoint
Baseline and after the intervention period
Method of measurement
24-hrs recall for 3-days

5

Description
Dietary caffeine intake
Timepoint
Baseline and after the intervention period
Method of measurement
24-hrs recall for 3-days

6

Description
Weight
Timepoint
Baseline and after the intervention period
Method of measurement
Scale

7

Description
Physical activity
Timepoint
Baseline and after the intervention period
Method of measurement
Physical activity questionnaire

8

Description
Depression
Timepoint
Baseline and after the intervention period
Method of measurement
SCL-90 questionnaire

9

Description
Quality of life
Timepoint
Baseline and after the intervention period
Method of measurement
GHQ-28

10

Description
loose stool
Timepoint
Baseline and after the intervention period
Method of measurement
Asking

Intervention groups

1

Description
Intervention group will receive 250 mg magnesium supplement tablets. Bid for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group will receive 250 mg placebo tablets containing starch. Bid for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of
Full name of responsible person
Mrs.Parmar
Street address
Dastgheib St., Ostad Moeen Ave., َAzadi Ave., Azadi Sq.
City
Tehran

2

Recruitment center
Name of recruitment center
Amirkabir Cultural Center
Full name of responsible person
Mrs.Kaviani
Street address
Gheytarie St, Saba Ave,Shariati Ave.
City
Tehran

3

Recruitment center
Name of recruitment center
Salmand caltural center
Full name of responsible person
Mrs.Sharar
Street address
Khoshkbarchi St., 17 Shahrivar Avn., Imam Hossein Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National nutrition and food technology research institute - Shahid Beheshty university of medical sc
Full name of responsible person
Dr.M.H.Faraji
Street address
No.46, West Arghavan St., Farahzadi Blvd., Shahrake Gharb
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National nutrition and food technology research institute - Shahid Beheshty university of medical sc
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
National nutrition and food technology research institute-Shahid Beheshti University of Medical Scie
Full name of responsible person
Behnood Abbasi
Position
M.Sc. Student
Other areas of specialty/work
Street address
Velenjak Street, Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Phone
+98 21 8870 4487
Fax
Email
b.abbasi@nnftri.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
National nutrition and food technology research institute-Shahid Beheshti University of Medical Scie
Full name of responsible person
Masud Kimiagar
Position
Professor
Other areas of specialty/work
Street address
Velenjak Street, Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Phone
+98 21 2212 4333
Fax
Email
smkimiagar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
National nutrition and food technology research institute-Shahid Beheshti University of Medical Scie
Full name of responsible person
Behnood Abbasi
Position
M.Sc. Student
Other areas of specialty/work
Street address
Velenjak Street, Shahid Chamran Highway
City
Tehran
Postal code
Phone
+98 21 8870 4487
Fax
Email
b.abbasi@nnftri.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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