Plain English Summary
Background and study aims
The term sarcopenia means the loss of muscle mass and muscle function with age, especially among elderly people. Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in muscle mass and muscle strength. The aim of this study is to examine the effect of vitamin D supplementation on muscle mass and strength in sarcopenic older Lebanese people.
Who can participate?
Adults aged 71-77 who are deficient in vitamin D.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive vitamin D supplments. Those in the second group receive a dummy supplement. Participants take the supplement for six months. Participants are followed up to assess strength and functional assessment and biochemical analysis after six months to see if they have improved.
What are the possible benefits and risks of participating?
Participants may benefit from vitamin D supplementation as it may improve muscle strength and sarcopenia. No risks are involved in the participants taking part in the study.
Where is the study run from?
Hopital Saint Charles (Lebanon)
When is the study starting and how long is it expected to run for?
August 2014 to December 2015
Who is funding the study?
Saint Charles Hospital (Lebanon)
Who is the main contact?
Miss El Hajj Cynthia (Scientific)
cynthiaeliashajj102@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Miss El Hajj Cynthia
ORCID ID
Contact details
Universite d’Auvergne
49 Boulevard François Mitterrand
Clermont-Ferrand
63000
France
+33 4 73 60 82 76
cynthiaeliashajj102@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SSCC012
Study information
Scientific title
Vitamin D supplementation and muscle strength in sarcopenic elderly Lebanese people: A randomised controlled trial
Acronym
Study hypothesis
Vitamin D supplementation has beneficial effects on muscle strength and muscle mass in elderly.
Ethics approval
Ethics Committee Institutional Review Board Saint Charles Hospital, 11/02/2015, ref: SSCC012
Study design
Randomided controlled double blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sarcopenia and Vitamin D Deficiency
Intervention
In this randomized, controlled, double blind study, participants are randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving ) to be taken three times per week for a period of six months.
The participants are seen after six months of supplementation with vitamin D or placebo, and followed up by phone calls at three months.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Handgrip strength is measured using the Martin vigorimeter (Martin; Elmed, Addison, IL, USA), at baseline and 6 months.
2. Appendicular skeletal muscle mass is measured using bioimpedance analysis measurements (Tanita BC-418 Segmental Body Composition Analyzer, Illinois, USA) at baseline and 6 months.
3. 25 (OH)D levels are measured using radioimmunoassay (DiaSorin, Stillwater, MN) at baseline and 6 months
Secondary outcome measures
1. Weight is measured using the body composition analyzer (Tanita BC-418 Segmental Body Composition Analyzer, Illinois, USA) at baseline and 6 months
2. BMI is calculated using the standard formula (body weight in kilograms divided by square of body height in meters). at baseline and 6 months
3. Waist circumference is measured at the iliac crest at baseline and 6 months
4. Fat Mass is measured using the body composition analyzer (Tanita BC-418 Segmental Body Composition Analyzer, Illinois, USA) at baseline and 6 months
5. PTH is measured using a two-site immunoradiometric assay with an NH2-terminal monoclonal antibody as capture (Fitzgerald Industries International Inc., USA), at baseline and 6 months
6. Serum creatinine is measured using the Jaffe kineticalkaline picrate reaction (Interpretation and Techniques, Lea and Febiger, Philadelphia), at baseline and 6 months
Overall trial start date
02/08/2014
Overall trial end date
04/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Sarcopenic
2. Deficient in vitamin D
3. No medical history of type-2 diabetes
4. Age range of participants: 71-77
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
115
Participant exclusion criteria
1. Sarcopenic subjects
2. Incidence of balance problems due to neurological disorders
3. Renal failure
4. Congestive heart failure and acute heart insufficiency as well as uncontrolled arterial hypertension or hypotension
5. Use of sedative (that could affect balance)
6. Use of vitamin D supplementation
7. Primary hyperparathyroidism
Recruitment start date
02/07/2015
Recruitment end date
19/09/2015
Locations
Countries of recruitment
Lebanon
Trial participating centre
Hopital Saint Charles
Fiyadiyeh- Baabda
Beirut
50
Lebanon
Sponsor information
Organisation
Universite d’Auvergne
Sponsor details
49 Boulevard François Mitterrand
Clermont-Ferrand
63000
France
Sponsor type
Other
Website
Funders
Funder type
Not defined
Funder name
Saint Charles Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication. Study protocol, statistical analysis plan, and others are available.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Cynthia El Hajj
Email address: cynthiaeliashajj102@gmail.com
Intention to publish date
02/04/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30569340