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The effects of magnesium supplement on muscle strength, muscle function, and inflammatory markers in middle-aged women.

Protocol summary

Summary
We have designed a double-blind, placebo-controlled, randomized trial to investigate whether magnesium supplementation improves muscle function, strength and inflammatory state. Eighty women, aged 45-55 years old, stopped menstrual cycle for at least 12 month, who is eligible for this study, will be recruited from Iran medical university. Participants will be divided in two groups randomly, receiving either 250 mg magnesium in the form of magnesium Oxide or placebo for 8 weeks. Handgrip strength, Knee extension strength and time get up and go test (muscle strength and function markers), IL-6, hs-CRP, and fibrinogen (inflammatory markers) will be measured at the baseline and the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138805312365N1
Registration date: 2010-01-09, 1388/10/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-01-09, 1388/10/19
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chanceller of Research, Iran University of Medical Sciences
Expected recruitment start date
2009-11-26, 1388/09/05
Expected recruitment end date
2010-03-06, 1388/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of magnesium supplement on muscle strength, muscle function, and inflammatory markers in middle-aged women.
Public title
The effects of magnesium supplement on muscle strength, muscle function, and inflammatory markers in middle-aged women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age 45 to 55 years old 2. Stopped menstrual cycle for at least 12 month 3. Voluntary participation Exclusion criteria: 1. BMI less than 25 Kg/m2 2. Having one of the following diseases: uncontrolled hypertension, Diabetes, cardiovascular diseases, asthma, Thyroid or parathyroid diseases, renal disorders, liver diseases, bone or rheumatoid disorders, gastrointestinal diseases, and infectious diseases 3. Taking any supplements including minerals, vitamins, and ω-3 fatty acids 4. Receiving hormonal products 5. Cigarette smoking 6. Using one of the following medications: anti-inflammatory drugs (including NSAIDs, steroids, salicylates), aminoglycosides antibiotics, Laxative drug, magnesium-containing drugs 7. compliance less than 70%
Age
From 45 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of health, Iran university of Medical Sciences
Street address
school of Health, Arjantin Square, Alvand Ave., Tehran
City
Tehran
Postal code
1516846514
Approval date
empty
Ethics committee reference number
2155/د5/26/پ

Health conditions studied

1

Description of health condition studied
Decrease of muscle strength
ICD-10 code
M62.5
ICD-10 code description
Muscle wasting and atrophy, not elsewhere classified

Primary outcomes

1

Description
Muscle strength in hand and foot
Timepoint
8 weeks
Method of measurement
Dynamometer, Handgrip

Secondary outcomes

1

Description
Inflamentory markers
Timepoint
8 weeks after intervention
Method of measurement
decline of inflamentory marker

Intervention groups

1

Description
Dietary Magnesium supplement, 250 mg, for 8 weeks
Category
Prevention

2

Description
Placebo, the same tablets as the active drug with the same dose for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Street address
school of health, Arjantin square, Alvand Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran Univesity of Medical Sciences
Full name of responsible person
Dr Mohsen Asadi Lari
Street address
Iran University of Medical Sciences, Hematt express way,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Univesity of Medical Sciences
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
school of health, Arjantin square, Alvand Ave.
City
Tehran
Postal code
1516846514
Phone
+98 21 8877 9118
Fax
+98 21 8877 9487
Email
rezavafa@iums.ac.ir, rezavafa@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

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