Vitamin D supplementation and muscle strength in sarcopenic and obese sarcopenic elderly Lebanese people

ISRCTN	ISRCTN10618249
DOI	https://doi.org/10.1186/ISRCTN10618249
Protocol serial number	1.2
Sponsor	Hôpital St. Charles
Funder	Saint Charles Hospital

Submission date: 02/06/2017
Registration date: 06/06/2017
Last edited: 14/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims:
Sarcopenia is a condition associated with old age, which involves loss of muscle mass and strength. This can lead to problems with balance and movement, increasing the risk of falling and fractures in the elderly. Vitamin D is essential for good health, because it helps our bodies to absorb calcium from the diet. There is a lot of evidence that having enough vitamin D plays an important role in muscle and bone health. Although vitamins generally come from the diet, in the case of vitamin D, the majority of people actually get most of it from sunlight. Vitamin D deficiency or insufficiency is a common health problem in older adults. It has been found that obese older adults have low vitamin D levels and low muscle strength and mass (sarcopenic obesity). The aim of this study is to look at the effects of vitamin D supplementation on sarcopenic individuals and individuals with sarcopenic obesity.

Who can participate?
Adults aged 70 and over who are deficient in vitamin D.

What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first and third group are obese and those in the second and fourth group are of normal weight. In each pair of groups, one group receives a weekly supplement of vitamin D for six months, and the other receives a weekly supplement containing a placebo (dummy pill) for six months. At the start of the study and then six months later, participants have a blood test to assess their vitamin D levels, as well as being weighed and taking parts in assessments of muscle strength and function.

What are the possible benefits and risks of participating?
Participants who receive the vitamin D may benefit from improved muscle strength and function. There is a small risk of pain or bruising when blood samples are collected.

Where is the study run from?
Saint Charles Hospital (Lebanon)

When is study starting and how long is it expected to run for?
April 2015 to September 2015

Who is funding the study?
Saint Charles Hospital (Lebanon)

Who is the main contact?
Ms Cynthia El Hajj
cynthiaeliashajj102@gmail.com

Contact information

Ms Cynthia El Hajj
Scientific

Hôpital St. Charles
Fiyadiyeh
Baabda
13008
France

Phone	+33 601 465 473
Email	cynthiaeliashajj102@gmail.com

Study information

Primary study design	Interventional
Study design	Interventional randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of vitamin D supplementation on muscle mass and strength in sarcopenic and obese sarcopenic older Lebanese people
Study objectives	The aim of this study is to evaluate the effects of weekly supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) over 6 months on muscle strength and sarcopenia. Null hypothesis: Vitamin D supplementation will not have effect on muscle strength and sarcopenia of the participants. Alternative hypothesis: Vitamin D supplementation will increase muscle mass and decrease sarcopenia of the participants.
Ethics approval(s)	Committee Ethical Approval Form (CEAF) of Saint Charles Hospital, 11/05/2015, ref: 11/5
Health condition(s) or problem(s) studied	Vitamin D deficiency
Intervention	Participants are randomised to one of four groups. Those in group one and three have a BMI over 30 and those in groups two and four have a BMI within the normal range. Group 1: Participants receive a weekly supplement of 10,000 IU cholecalciferol (vitamin D) for 6 months Group 2: Participants receive a weekly supplement of 10,000 IU cholecalciferol (vitamin D) for 6 months Group 3: Participants receive a weekly supplement of a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) for 6 months Group 4: Participants receive a weekly supplement of a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) for 6 months Follow up takes place after six months and involves phone calls every three months and assessment at baseline and after 6 months of supplementation.
Intervention type	Supplement
Primary outcome measure(s)	All primary outcomes are assessed at baseline and after 6 months of intervention. 1. Vitamin D (25(OH)D) is measured by radioimmunoassay (DiaSorin, Stillwater, MN) 2. Handgrip strength is measured in the dominant hand with a Martin vigorimeter (Martin; Elmed, Addison, IL, USA), and the force was expressed in kilograms (kg) 3. Skeletal muscle mass is anticipated from bioimpedance analysis measurements (Tanita BC-418 Segmental Body Composition Analyzer, Illinois, USA) and expressed as appendicular skeletal muscle mass (ASMM, kg) 4. Total lean body mass is measured using Tanita BC-418 Segmental Body Composition Analyzer, Illinois, USA 5. Fat mass is measured using Tanita BC-418 Segmental Body Composition Analyzer, Illinois, USA 6. Parathyroid hormone is measured using a two-site immunoradiometric assay with an NH2-terminal monoclonal antibody as capture (Fitzgerald Industries International Inc., USA)
Key secondary outcome measure(s)	All secondary outcomes are assessed at baseline and after 6 months of intervention. 1. Weight (kg) is assessed using the body composition analyzer (Tanita BC-418 Segmental Body Composition Analyzer, Illinois,USA) 2. Body mass index (BMI) is calculated using the standard formula (body weight in kilograms divided by the square of the body height in meters [kg/m²]) 3. Serum creatinine is measured using the Jaffe rate method, the kinetic alkaline picrate (Interpretation and Techniques, Lea and Febiger, Philadelphia)
Completion date	30/09/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Senior
Sex	All
Target sample size at registration	116
Key inclusion criteria	1. Deficient in vitamin D 2. Age 70 years and over 3. No medical history of type 2 diabetes, congestive heart failure, renal failure or acute heart insufficiency
Key exclusion criteria	1. Not deficient in vitamin D 2. Under 70 years of age 3. Having a medical history of type 2 diabetes, congestive heart failure, renal failure or acute heart insufficiency
Date of first enrolment	02/07/2015
Date of final enrolment	30/09/2015

Locations

Countries of recruitment

France
Lebanon

Study participating centre

Saint Charles Hospital

Fayadié-Baabda-Liban
Beirut
50
France

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Cynthia El Hajj (cynthiaeliashajj102@gmail.com)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/07/2017: Intention to publish date has been added.