Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/02/2018
Date assigned
20/02/2018
Last edited
19/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www6.clermont.inra.fr/unh/Equipes-de-Recherche/ASMS/Composition-de-l-equipe/Dr-Stephane-WALRAND

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

Publication citations

Additional files

Editorial Notes