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IRCT20090822002365N20 IRCT 2018-03-10 personal (expenses will payed by student) The effects of magnesium and vitamin D supplement on muscle strength, muscle function, and inflammatory markers in middle-aged women. The effects of magnesium and vitamin D supplement on muscle strength, muscle function, and inflammatory markers in middle-aged women. 2018-04-04 anticipated 90 Complete https://irct.ir/trial/2026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 90 subjects, 23 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will enter based on the sequence produced into study and the drug packets with code registered will allocate to the individual. Therefore, before participants selection, they will be unaware of the type of intervention that will receive, as well as a random sequence produced during the study will be immune from prediction, Blinding description: In order to performing the double-blinded of study, before study beginning, the canisters containing tablets can be provided by someone other than the researcher, and the placebo tablets in appearance are similar to the supplementation tablets and the researcher are not be aware about the allocation of studied subjects in each group during the evaluation of the studied outcomes until the end of the intervention period. 3 Sarcopenia, muscle weakness, decrease of muscle strength. Intervention 1: Intervention group: Daily intake of one magnesium supplement (250 mg) and weekly intake of vitamin D (50000 IU) for 8 weeks (2 months). Intervention 2: Control group: Daily intake of one placebo magnesium tablet (containing Maltodextrin) and weekly intake of one vitamin D tablet (containing Maltodextrin) for 8 weeks (2 months). Yes - There is a plan to make this available What will be shared: Only a section of the data, such as primary outcomes information or the like, will be shared. When: Access period start 6 months after results publishing To whom: The obtained data from current study will be available only for working researchers in academic and scientific institutions Conditions: Six months after the publicated papers from this study, the obtained data will be available to the researchers for further analysis Where to obtain: Applicants can be communicated to correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran university of Medical Sciences, Hemat Express way, Tehran Cell phone:+98 21 8670 4743 Email:vafa.m@iums.ac How to obtain: Applicants will be given access to the obtained data from current study by sending an email to the correspond author Comments:
public Mohammad Reza Vafa
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4734 vafa.m@iums.ac.ir Iran University of Medical science scientific Mohammad Reza Vafa
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4734 vafa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Voluntary participation Age from 40 to 55 years old BMI>=25kg/m2 Having serum vitamin D less than 30 ng/ml 40 years 55 years Female M62.5 Muscle wasting and atrophy ,not elsewhere classified Treatment - Drugs Placebo Intervention group: Daily intake of one magnesium supplement (250 mg) and weekly intake of vitamin D (50000 IU) for 8 weeks (2 months) Control group: Daily intake of one placebo magnesium tablet (containing Maltodextrin) and weekly intake of one vitamin D tablet (containing Maltodextrin) for 8 weeks (2 months) Improvement of muscle strength in hand and foot. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Dynamometer, Handgrip. Hs-CRP. Timepoint: Before the intervention and two months later of intervention. Method of measurement: immunoturbidimetry. TNF-α. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of TNF-α in serum using ELISA kit. IL-6. Timepoint: Before the intervention and two months later of intervention. Method of measurement: Concentration of IL-6 in serum using ELISA kit. personal (expenses will payed by student) Approved 2017-10-27 Ethics committee of Iran University of Medical Science Hemmat Express way, Iran University of Medical Science Tehran Tehran Iran (Islamic Republic of)