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

• Register: ISRCTN
• Last refreshed on: 21 August 2017
• Main ID: ISRCTN10618249
• Date of registration: 06/06/2017
• Prospective Registration: No
• Primary sponsor: Hôpital St. Charles
• Public title: Vitamin D supplementation and muscle strength in sarcopenic and obese sarcopenic elderly Lebanese people
• Scientific title: Effect of vitamin D supplementation on muscle mass and strength in sarcopenic and obese sarcopenic older Lebanese people
• Date of first enrolment: 02/07/2015
• Target sample size: 116
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10618249
• Study type: Interventional
• Study design: Interventional randomised controlled trial (Other)

Countries of recruitment

Lebanon

Contacts

• Name: Cynthia El Hajj

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Vitamin D deficiency
Nutritional, Metabolic, Endocrine
Vitamin D deficiency

Intervention(s)

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.

Primary Outcome(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)

Secondary Outcome(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)

Secondary ID(s)

1.2

Source(s) of Monetary Support

Saint Charles Hospital