Sarcopenia، the loss of muscle mass and strength with aging، is a common cause of functional limitations، disability and mortality in older age which is reversible and preventable. Previous cross-sectional and prospective studies suggested vitamin D deficiency is common in elderly people and is associated with muscle weakness، weight gain، and increased risk of sarcopenia in older adults. However، effect of vitamin D supplement on body composition، muscle strength and muscle function is not clear. Therefore، we have designed a double blind، Placebo-controlled، randomized clinical trial to investigate the effect of vitamin D supplement consumption on muscle strength، muscle function and body composition in middle aged women. 74 women، aged 40-50 years old، who are eligible for this study will be recruited from Iran medical university. Informed consent form will be completed by each participant at the beginning of study. Participants will be divided in two groups randomly، receiving either 1000 IU vitamin D tablet or placebo for 12 weeks. Muscle strength and function markers (handgrip strength، knee extension strength، time get up and go) and body composition will be determined at baseline and the end of the study. Key words: sarcopenia، muscle strength، muscle function، body composition، vitamin D
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112182365N6
Registration date:2014-12-22, 1393/10/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-22, 1393/10/01
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
2014-12-06, 1393/09/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplement consumption on muscle strength, muscle function and body composition in middle-aged women
Public title
Effect of vitamin D supplement consumption on muscle strength, muscle function and body composition in middle-aged women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy، aged 40-55 years old women; Premenopaused; BMI 18.5-29.9 kg/m2; 25(OH)-D<25 nmol/l; Not ovariectomized; Women must be with out following diseases: uncontrolled hypertension; diabetes; cardiovascular diseases; renal disorders; asthma; liver diseases; thyroid or parathyroid diseases; bone disorders; gastrointestinal diseases; infectious diseases and hyperphosphatemia; Not taking W3 fatty acids or fish oil; hormonal products، any supplements including vitamins and minerals; Not using one of the following medications: anti inflammatory drugs (including NSAIDs and steroids); phenobarbital، phenytoin; anti acid drugs، diuretics and laxative drugs; Not using any drug and supplement have effect on weight status; Voluntary participitation.
Exclusion criteria: Acute disease; Migration; Any event that effect on health status
Age
From 40 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
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
Tehran، Hemat Express way، Iran University of Medical Sciences، School of Health
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
24988-93/9/8
2
Ethics committee
Name of ethics committee
School of health, Iran university of Medical Sciences
Street address
Tehran, Hemat express way, Iran university of Medical Sciences, School of Public Health
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
24988-93/8/4
Health conditions studied
1
Description of health condition studied
Sarcopenia, Muscle weakness, Decrease of muscle strength
ICD-10 code
M62.5
ICD-10 code description
Muscle wasting and atrophy, not elsewhere classified
Primary outcomes
1
Description
Improvement of muscle strength in hand and foot, Improvement of body composition
Timepoint
12 weeks
Method of measurement
Dynamometer, Handgrip, BIA
Secondary outcomes
1
Description
Increase of serum 25(OH)-D
Timepoint
12 weeks
Method of measurement
Laboratory Kit
Intervention groups
1
Description
Vitamin D supplement in a DRI dose
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Street address
Hemat Expressway, Iran University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Ali Javadmoosavi
Street address
Hemat Express way, Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University 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
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran, Hemat Express way, Iran University of Medical Sciences, School of Public Health, Nutrition Department
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
rezavafa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran, Hemat Express way, Iran University of Medical Sciences, School of Public Health
City
Tehran
Postal code
Phone
+98 21 8670 4734
Fax
Email
rezavafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)